International Journal of Pharmaceutical Research and Applications

Volume 7, Issue 1 Jan-Feb 2022, pp: 219-229 www.ijprajournal.com ISSN: 2249-7781

An Overview on Cancer
Menaz Kamruddin Kachhi*1 and Dr. Kiran B. Dhamak1
Department of Quality Assurance, Pravara Rural Education Society’s College of Pharmacy for Women’s,
Chincholi, Nashik, MS,India.

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Submitted: 01-01-2022 Accepted: 10-01-2022
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ABSTRACT due to inherited genetic defects Cancer can be
Presently a day's malignant growth is the most detected by certain signs and symptoms
predominant perilous infection which is spreading or screening tests. It is then typically further
a result of the way of life we are living. investigated by medical imaging and confirmed
Malignancy is because of uncontrolled by biopsy.[8]
development of cell which can be restored The risk of developing certain cancers can
whenever analyzed in ahead of schedule phase of be reduced by not smoking, maintaining a healthy
life. Therapy of malignant growth relies upon the weight, limiting alcohol intake, eating plenty
different inner and outer variables causing disease. of vegetables, fruits,and wholegrains, vaccination a
Malignant growth is screened by various screening gainst certain infectious diseases, limiting
test and various medicines are currently accessible consumption of processed meat and red meat, and
these days such as quality treatment, limiting exposure to direct sunlight[9] Early
chemotherapy, medical procedure, radiation detection through screening is useful
treatment, immunotherapy and so on In future up to for cervical and colorectal cancer. [10] The benefits
2030 around 22.2 million cases are relied upon to of screening for breast cancer are controversial.
be analyzed for malignant growth. Cancer is often treated with some combination
Key-words: cancer, carcinoma, carcinogen, of radiationtherapy,surgery, chemotherapy and targ
therapy, treatment eted therapy. Pain and symptom management are
an important part of care. Palliative care is
I. INTRODUCTION particularly important in people with advanced
Cancer is a group disease. The chance of survival depends on the type
of diseases involving abnormal cell growth with the of cancer and extent of disease at the start of
potential to invade or spread to other parts of the treatment. In children under 15 at diagnosis,
body.[1-2] These contrast with benign tumors, the five-year survival rate in the developed world is
which do not spread. Possible signs and on average 80%.For cancer in the United States,
symptoms include a lump, abnormal bleeding, the average five-year survival rate is 66%.
prolonged cough, unexplained weight loss, and a In 2015, about 90.5 million people had
change in bowel movements. While these cancer. As of 2019, about 18 million new cases
symptoms may indicate cancer, they can also have occur annually. Annually, it caused about 8.8
other causes. Over 100 types of cancers affect million deaths (15.7% of deaths). The most
humans. Tobacco use is the cause of about 22% of common types of cancer in males are lung
cancer deaths. Another 10% are due to obesity, cancer, prostate cancer, colorectal cancer,
poor diet, lack of physical activity or excessive and stomach cancer.[11] In females, the most
drinking of alcohol.[3-5] Other factors include common types are breast cancer, colorectal cancer,
certain infections, exposure to ionizing radiation, lung cancer, and cervical cancer. If skin
and environmental pollutants. In the developing cancer other than melanoma were included in total
world, 15% of cancers are due to infections such new cancer cases each year, it would account for
as Helicobacter pylori, hepatitis B, hepatitis around 40% of cases. In children, acute
C, human papillomavirus infection, Epstein–Barr lymphoblastic leukemia and brain tumors are most
virus and human immunodeficiency common, except in Africa, where non-Hodgkin
virus (HIV). These factors act, at least partly, by lymphoma occurs more often. In 2012, about
changing the genes of a cell.[6] Typically, many 165,000 children under 15 years of age were
genetic changes are required before cancer diagnosed with cancer. The risk of cancer increases
develops.[7] Approximately 5–10% of cancers are significantly with age, and many cancers occur

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Volume 7, Issue 1 Jan-Feb 2022, pp: 219-229 www.ijprajournal.com ISSN: 2249-7781

more commonly in developed countries. Rates are inflammatory state that leads to ongoing muscle
increasing as more people live to an old age and as loss and weakness, known as cachexia.
lifestyle changes occur in the developing Some types of cancer such as Hodgkin
world. The financial costs of cancer were estimated disease, leukemias and cancers of the
at 1.16 trillion USD per year as of 2010. liver or kidney can cause a persistent fever.[13]
Etymology and definitions Metastasis
The word comes from the ancient Greek Metastasis is the spread of cancer to other
καρκίνος, meaning crab and tumor. Greek locations in the body. The dispersed tumors are
physicians Hippocrates and Galen, among others, called metastatic tumors, while the original is
noted the similarity of crabs to some tumors with called the primary tumor. Almost all cancers can
swollen veins. The word was introduced in English metastasize. Most cancer deaths are due to cancer
in the modern medical sense around 1600. Cancers that has metastasized.[14]
comprise a large family of diseases that involve Causes
abnormal cell growth with the potential to invade It is not generally possible to prove what
or spread to other parts of the body. They form a caused a particular cancer because the various
subset of neoplasms. A neoplasm or tumor is a causes do not have specific fingerprints. For
group of cells that have undergone unregulated example, if a person who uses tobacco heavily
growth and will often form a mass or lump, but develops lung cancer, then it was probably caused
may be distributed diffusely.[12] by the tobacco use, but since everyone has a small
Signs and symptoms chance of developing lung cancer as a result of air
When cancer begins, it produces no pollution or radiation, the cancer may have
symptoms. Signs and symptoms appear as the mass developed for one of those reasons. Excepting the
grows or ulcerates. The findings that result depend rare transmissions that occur with pregnancies and
on the cancer's type and location. Few symptoms occasional organ donors, cancer is generally not
are specific. Many frequently occur in individuals a transmissible disease, however factors that may
who have other conditions. Cancer can be difficult have contributed to the development of cancer can
to diagnose and can be considered a "great be transmissible; such as Oncoviruses like hepatitis
imitator." B, Epstein-Barr virus and HIV.
Local symptoms Diet and exercise
Local symptoms may occur due to the Diet, physical inactivity and obesity are
mass of the tumor or its ulceration. For example, related to up to 30–35% of cancer deaths. In the
mass effects from lung cancer can block United States, excess body weight is associated
the bronchus resulting in cough with the development of many types of cancer and
or pneumonia; esophageal cancer can cause is a factor in 14–20% of cancer deaths. A UK study
narrowing of the esophagus, making it difficult or including data on over 5 million people showed
painful to swallow; and colorectal cancer may lead higher body mass index to be related to at least 10
to narrowing or blockages in the bowel, affecting types of cancer and responsible for around 12,000
bowel habits. Masses in breasts or testicles may cases each year in that country. Physical inactivity
produce observable lumps. Ulceration can cause is believed to contribute to cancer risk, not only
bleeding that can lead to symptoms such through its effect on body weight but also through
as coughing up blood (lung negative effects on the immune
cancer), anemia or rectal bleeding (colon system and endocrine system. More than half of the
cancer), blood in the urine (bladder cancer), effect from diet is due to over nutrition (eating too
or abnormal vaginal bleeding (endometrial or much), rather than from eating too few vegetables
cervical cancer). Although localized pain may or other healthful foods.[15]
occur in advanced cancer, the initial tumor is Infection
usually painless. Some cancers can cause a buildup Oncoviruses (viruses that can cause
of fluid within the chest or abdomen. cancer) include human papillomavirus (cervical
Systemic symptoms cancer), Epstein–Barr virus (B-cell
Systemic symptoms may occur due to the lymphoproliferative disease and nasopharyngeal
body's response to the cancer. This may include carcinoma), Kaposi's sarcoma
fatigue, unintentional weight loss, or skin herpesvirus (Kaposi's sarcoma and primary
changes. Some cancers can cause a systemic effusion lymphomas), hepatitis B and hepatitis
C viruses (hepatocellular carcinoma) and human T-

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Volume 7, Issue 1 Jan-Feb 2022, pp: 219-229 www.ijprajournal.com ISSN: 2249-7781

cell leukemia virus-1 (T-cell leukemias). Bacterial injuries to the same tissues might promote
infection may also increase the risk of cancer, as excessive cell proliferation, which could then
seen in Helicobacter pylori-induced gastric increase the odds of a cancerous mutation.[17]
carcinoma. Parasitic infections associated with Hormones
cancer include Schistosoma Some hormones play a role in the
haematobium (squamous cell carcinoma of the development of cancer by promoting cell
bladder) and the liver flukes, Opisthorchis proliferation. Insulin-like growth factors and their
viverrini and Clonorchis binding proteins play a key role in cancer cell
sinensis (cholangiocarcinoma)[16] proliferation, differentiation and apoptosis,
Radiation suggesting possible involvement in carcinogenesis.
Radiation exposure such as ultraviolet Autoimmune diseases
radiation and radioactive material is a risk factor There is an association between celiac
for cancer. Many non-melanoma skin cancers are disease and an increased risk of all cancers. People
due to ultraviolet radiation, mostly from with untreated celiac disease have a higher risk, but
sunlight. Sources of ionizing radiation this risk decreases with time after diagnosis and
include medical imaging and radon gas. strict treatment, probably due to the adoption of
Medical use of ionizing radiation is a a gluten-free diet, which seems to have a protective
small but growing source of radiation-induced role against development of malignancy in people
cancers. Ionizing radiation may be used to treat with celiac disease. However, the delay in
other cancers, but this may, in some cases, induce a diagnosis and initiation of a gluten-free diet seems
second form of cancer. It is also used in some kinds to increase the risk of malignancies.[18]
of medical imaging. Pathophysiology
Heredity Cancers are caused by a series of mutations. Each
The vast majority of cancers are non- mutation alters the behavior of the cell somewhat.
hereditary (sporadic). Hereditary cancers are
primarily caused by an inherited genetic defect. Genetics
Less than 0.3% of the population are carriers of a Cancer is fundamentally a disease of
genetic mutation that has a large effect on cancer tissue growth regulation. In order for a normal cell
risk and these cause less than 3–10% of to transform into a cancer cell, the genes that
cancer. Some of these syndromes include: certain regulate cell growth and differentiation must be
inherited mutations in the altered. The affected genes are divided into two
genes BRCA1 and BRCA2 with a more than 75% broad categories. Oncogenes are genes that
risk of breast cancer and ovarian promote cell growth and reproduction. Tumor
cancer, and hereditary nonpolyposis colorectal suppressor genes are genes that inhibit cell division
cancer (HNPCC or Lynch syndrome), which is and survival. Malignant transformation can occur
present in about 3% of people with colorectal through the formation of novel oncogenes, the
cancer, among others. inappropriate over-expression of normal
Physical agents oncogenes, or by the under-expression or disabling
Physical trauma resulting in cancer is of tumor suppressor genes. Typically, changes in
relatively rare. Claims that breaking bones resulted multiple genes are required to transform a normal
in bone cancer, for example, have not been proven. cell into a cancer cell.
Similarly, physical trauma is not accepted as a Epigenetics
cause for cervical cancer, breast cancer or brain The central role of DNA damage and
cancer. One accepted source is frequent, long-term epigenetic defects in DNA repair genes in
application of hot objects to the body. It is possible carcinogenesis
that repeated burns on the same part of the body, The classical view of cancer is a set of
such as those produced by kanger and kairo heaters diseases that are driven by progressive genetic
(charcoal hand warmers), may produce skin cancer, abnormalities that include mutations in tumor-
especially if carcinogenic chemicals are also suppressor genes and oncogenes and chromosomal
present. Frequent consumption of scalding hot tea abnormalities. Later epigenetic alterations' role was
may produce esophageal cancer. Generally, it is identified[19]
believed that cancer arises, or a pre-existing cancer Epigenetic alterations are functionally
is encouraged, during the process of healing, rather relevant modifications to the genome that do not
than directly by the trauma. However, repeated change the nucleotide sequence. Examples of such

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Volume 7, Issue 1 Jan-Feb 2022, pp: 219-229 www.ijprajournal.com ISSN: 2249-7781

modifications are changes in DNA Sarcoma: Cancers arising from connective

methylation (hypermethylation and tissue (i.e. bone, cartilage, fat, nerve), each of
hypomethylation), histone modification[93] and which develops from cells originating
changes in chromosomal architecture (caused by in mesenchymal cells outside the bone marrow.
inappropriate expression of proteins such Lymphoma and leukemia: These two classes arise
as HMGA2 or HMGA1) [20] Each of these from hematopoietic (blood-forming) cells that
alterations regulates gene expression without leave the marrow and tend to mature in the lymph
altering the underlying DNA sequence. These nodes and blood, respectively[22]
changes may remain through cell divisions, last for Germ cell tumor: Cancers derived
multiple generations and can be considered to be from pluripotent cells, most often presenting in
epimutations (equivalent to mutations). the testicle or
Epigenetic alterations occur frequently in the ovary (seminoma and dysgerminoma,
cancers. As an example, one study listed protein respectively).
coding genes that were frequently altered in their Blastoma: Cancers derived from immature
methylation in association with colon cancer. These "precursor" cells or embryonic tissue. Cancers are
included 147 hypermethylated and 27 usually named using -carcinoma, -sarcoma or -
hypomethylated genes. Of the hypermethylated blastoma as a suffix, with the Latin or Greek word
genes, 10 were hypermethylated in 100% of colon for the organ or tissue of origin as the root. For
cancers and many others were hypermethylated in example, cancers of the liver parenchyma arising
more than 50% of colon cancers[21] While from malignant epithelial cells is
epigenetic alterations are found in cancers, the called hepatocarcinoma, while a malignancy arising
epigenetic alterations in DNA repair genes, causing from primitive liver precursor cells is called
reduced expression of DNA repair proteins, may be a hepatoblastoma and a cancer arising from fat cells
of particular importance. Such alterations are is called a liposarcoma. For some common cancers,
thought to occur early in progression to cancer and the English organ name is used. For example, the
to be a likely cause of the genetic instability most common type of breast cancer is called ductal
characteristic of cancers. carcinoma of the breast. Here, the
Metastasis adjective ductal refers to the appearance of cancer
Metastasis is the spread of cancer to other under the microscope, which suggests that it has
locations in the body. The dispersed tumors are originated in the milk ducts.
called metastatic tumors, while the original is Benign tumors (which are not cancers) are named
called the primary tumor. Almost all cancers can using -oma as a suffix with the organ name as the
metastasize. Most cancer deaths are due to cancer root. For example, a benign tumor of smooth
that has metastasized. muscle cells is called a leiomyoma (the common
Diagnosis name of this frequently occurring benign tumor in
Most cancers are initially recognized the uterus is fibroid). Confusingly, some types of
either because of the appearance of signs or cancer use the -noma suffix, examples
symptoms or through screening. Neither of these including melanoma and seminoma.
leads to a definitive diagnosis, which requires the Prevention
examination of a tissue sample by a pathologist. Cancer prevention is defined as active
People with suspected cancer are investigated measures to decrease cancer risk. The vast majority
with medical tests. These commonly include blood of cancer cases are due to environmental risk
tests, X-rays, (contrast) CT scans and endoscopy. factors. Many of these environmental factors are
Classification controllable lifestyle choices. Thus, cancer is
Cancers are classified by the type of generally preventable. Between 70% and 90% of
cell that the tumor cells resemble and is therefore common cancers are due to environmental factors
presumed to be the origin of the tumor. These types and therefore potentially preventable.
include: Medication
Carcinoma: Cancers derived Medications can be used to prevent cancer
from epithelial cells. This group includes many of in a few circumstances [23] In the general
the most common cancers and include nearly all population, NSAIDs reduce the risk of colorectal
those in cancer; however, due to cardiovascular and
the breast, prostate, lung, pancreas and colon. gastrointestinal side effects, they cause overall
harm when used for prevention. Aspirin has been

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found to reduce the risk of death from cancer by cancer, skin cancer, and thyroid cancer as well as
about 7%.COX-2 inhibitors may decrease the rate other cancer types [28]
of polyp formation in people with familial Radiation
adenomatous polyposis; however, it is associated Radiation therapy involves the use
with the same adverse effects as NSAIDs. Daily of ionizing radiation in an attempt to either cure or
use of tamoxifen or raloxifene reduce the risk of improve symptoms. It works by damaging the
breast cancer in high-risk women. The benefit DNA of cancerous tissue, killing it. To spare
versus harm for 5-alpha-reductase inhibitor such normal tissues (such as skin or organs, which
as finasteride is not clear. radiation must pass through to treat the tumor),
Vaccination shaped radiation beams are aimed from multiple
Vaccines have been developed that exposure angles to intersect at the tumor, providing
prevent infection by some carcinogenic viruses. a much larger dose there than in the surrounding,
Human papillomavirus healthy tissue. As with chemotherapy, cancers vary
vaccine (Gardasil and Cervarix) decrease the risk in their response to radiation therapy [29]
of developing cervical cancer [24] The hepatitis B Surgery
vaccine prevents infection with hepatitis B virus Surgery is the primary method of
and thus decreases the risk of liver cancer [25] The treatment for most isolated, solid cancers and may
administration of human papillomavirus and play a role in palliation and prolongation of
hepatitis B vaccinations is recommended where survival. It is typically an important part of
resources allow. definitive diagnosis and staging of tumors, as
Chemotherapy biopsies are usually required. In localized cancer,
Chemotherapy is the treatment of cancer surgery typically attempts to remove the entire
with one or more cytotoxic anti-neoplastic drugs mass along with, in certain cases, the lymph
(chemotherapeutic agents) as part of a standardized nodes in the area. For some types of cancer this is
regimen. The term encompasses a variety of drugs, sufficient to eliminate the cancer [30]
which are divided into broad categories such Palliative care
as alkylating agents and antimetabolites Palliative care is treatment that attempts to
[26] Traditional chemotherapeutic agents act by help the patient feel better and may be combined
killing cells that divide rapidly, a critical property with an attempt to treat the cancer. Palliative care
of most cancer cells. includes action to reduce physical, emotional,
It was found that providing combined spiritual and psycho-social distress. Unlike
cytotoxic drugs is better than a single drug; a treatment that is aimed at directly killing cancer
process called the combination therapy; which has cells, the primary goal of palliative care is to
an advantage in the statistics of survival and improve quality of life.
response to the tumor and in the progress of the Immunotherapy
disease. A Cochrane review concluded that A variety of therapies
combined therapy was more effective to treat using immunotherapy, stimulating or helping
metastasized breast cancer. However, generally it is the immune system to fight cancer, have come into
not certain whether combination chemotherapy use since 1997. Approaches include antibodies,
leads to better health outcomes, when both survival checkpoint therapy, and adoptive cell transfer [31]
and toxicity are considered [27] Laser therapy
Targeted therapy is a form of Laser therapy uses high-intensity light to
chemotherapy that targets specific molecular treat cancer by shrinking or destroying tumors or
differences between cancer and normal cells. The precancerous growths. Lasers are most commonly
first targeted therapies blocked the estrogen used to treat superficial cancers that are on the
receptor molecule, inhibiting the growth of breast surface of the body or the lining of internal organs.
cancer. Another common example is the class It is used to treat basal cell skin cancer and the very
of Bcr-Abl inhibitors, which are used to early stages of others like cervical, penile, vaginal,
treat chronic myelogenous vulvar, and non-small cell lung cancer.
leukemia (CML). Currently, targeted therapies Alternative medicine
exist for many of the most common cancer types, Complementary and alternative cancer
including bladder cancer, breast cancer, colorectal treatments are a diverse group of therapies,
cancer, kidney cancer, leukemia, liver cancer, lung practices and products that are not part of
cancer, lymphoma, pancreatic cancer, prostate conventional medicine [32] "Complementary

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medicine" refers to methods and substances used RECENT DEVELOPMENT OF ANTI-

along with conventional medicine, while CANCER DRUGS [41-50]
"alternative medicine" refers to compounds used 1. Pralsetinib
instead of conventional medicine. Most On December 1, the FDA approved
complementary and alternative medicines for pralsetinib (Gavreto) for adult and pediatric
cancer have not been studied or tested using patients 12 years of age and older with advanced or
conventional techniques such as clinical trials. metastatic RET-mutant medullary thyroid cancer
Some alternative treatments have been investigated who require systemic therapy or RET fusion–
and shown to be ineffective but still continue to be positive thyroid cancer who require systemic
marketed and promoted. Cancer researcher Andrew therapy and who are radioactive iodine–refractory.
J. Vickers stated, "The label 'unproven' is On September 4, pralsetinib was granted
inappropriate for such therapies; it is time to assert accelerated approval for adult patients with
that many alternative cancer therapies have been metastatic RET fusion–positive non–small cell lung
'disproven'." cancer (NSCLC), as detected by an FDA-approved
Survival is worse in the developing world test. Both pralsetinib approvals were based on
[33-38] partly because the types of cancer that are findings from the open-label, multicenter,
most common there are harder to treat than those multicohort ARROW clinical trial
associated with developed countries. (ClinicalTrials.gov identifier NCT03037385).
Those who survive cancer develop a 2. Naxitamab
second primary cancer at about twice the rate of On November 25, naxitamab (Danyelz)
those never diagnosed. The increased risk is was approved in combination with granulocyte-
believed to be due to the random chance of macrophage colony-stimulating factor for pediatric
developing any cancer, the likelihood of surviving patients 1 year of age and older and adult patients
the first cancer, the same risk factors that produced with relapsed or refractory high-risk neuroblastoma
the first cancer, unwanted side effects of treating in the bone or bone marrow demonstrating a partial
the first cancer (particularly radiation therapy), and response, minor response, or stable disease to prior
to better compliance with screening. [39] therapy. Approval was based on findings from two
Predicting short- or long-term survival single-arm, open-label trials: Study 201
depends on many factors. The most important are (NCT03363373) and Study 12-230
the cancer type and the patient's age and overall (NCT01757626).
health. Those who are frail with other health 3. Pembrolizumab
problems have lower survival rates than otherwise On November 13, accelerated approval
healthy people. Centenarians are unlikely to was granted to pembrolizumab (Keytruda) in
survive for five years even if treatment is combination with chemotherapy for the treatment
successful. People who report a higher quality of of patients with locally recurrent unresectable or
life tend to survive longer. People with lower metastatic triple-negative breast cancer whose
quality of life may be affected by depression and tumors express PD-L1 (Combined Positive Score ≥
other complications and/or disease progression that 10), as determined by an FDA-approved test.
both impairs quality and quantity of life. Approval was based on findings from KEYNOTE-
Additionally, patients with worse prognoses may 355 (NCT02819518), a multicenter, double-blind,
be depressed or report poorer quality of life randomized, placebo-controlled trial. On October
because they perceive that their condition is likely 14, approval was extended for pembrolizumab for
to be fatal.[40] adult patients with relapsed or refractory classical
People with cancer have an increased risk Hodgkin lymphoma (HL) and pediatric patients
of blood clots in their veins which can be life- with refractory classical HL or classical HL that
threatening. The use of blood thinners such has relapsed after two or more lines of therapy.
as heparin decrease the risk of blood clots but have Approval in this setting was based on findings from
not been shown to increase survival in people with KEYNOTE-204 (NCT02684292), a phase III,
cancer. People who take blood thinners also have randomized, open-label trial. On June 29,
an increased risk of bleeding. Although extremely pembrolizumab was approved for the first-line
rare, some forms of cancer, even from an advanced treatment of patients with unresectable or
stage, can heal spontaneously. This phenomenon is metastatic microsatellite instability–high or
known as the spontaneous remission. mismatch repair–deficient colorectal cancer. This
approval was based on findings from KEYNOTE-

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177 (NCT02563002), a multicenter, international, setting was based on CheckMate 9LA

open-label, active-controlled, randomized trial. On (NCT03215706), a randomized, open-label trial.
June 24, pembrolizumab was approved for patients On May 15, the combination of nivolumab plus
with recurrent or metastatic cutaneous squamous ipilimumab was approved as first-line treatment for
cell carcinoma that is not curable by surgery or patients with metastatic NSCLC whose tumors
radiation. Approval was based on findings from the express PD-L1 (≥ 1%), as determined by an FDA-
multicenter, multicohort, nonrandomized, open- approved test, with no EGFR or ALK genomic
label KEYNOTE-629 trial (NCT03284424). On tumor aberrations. This approval was based on
June 16, accelerated approval was granted to CheckMate 227 (NCT02477826), a randomized,
pembrolizumab for adult and pediatric patients open-label, multipart trial. On March 10,
with unresectable or metastatic tumor mutational accelerated approval was granted to the
burden-high [≥ 10 mutations/megabase] solid combination of nivolumab and ipilimumab for
tumors, as determined by an FDA-approved test, patients with hepatocellular carcinoma who have
that have progressed following prior treatment and been previously treated with sorafenib. Approval
no satisfactory alternative treatment options. was based on cohort 4 of CheckMate 040
Approval was based on a multicenter, (NCT01658878) a multicenter, multicohort, open-
nonrandomized, open-label trial, KEYNOTE-158 label trial.
(NCT02628067). On April 28, accelerated approval 6. Azacitidine
was granted to a new dosing regimen of 400 mg On September 1, azacitidine tablets
every 6 weeks for pembrolizumab across all (Onureg) were approved for continued treatment of
currently approved adult indications, in addition to patients with AML who achieved first complete
the current 200 mg every-3-weeks dosing regimen. remission or complete remission with incomplete
This approval was based on cohort B of blood cell count recovery following intensive
KEYNOTE-555 (NCT03665597), an international, induction chemotherapy and who are not able to
single-arm, multicenter study. complete intensive curative therapy. This oral form
4. Venetoclax of azacitidine should not be substituted for
On October 16, approval was granted to intravenous or subcutaneous formulations, which
venetoclax (Venclexta) in combination with have different indications and dosing regimens.
azacitidine, decitabine, or low-dose cytarabine for Approval was based on findings from QUAZAR
untreated acute myeloid leukemia (AML). (NCT01757535), a multicenter, randomized,
Approval was based on findings from two double-blind, placebo-controlled trial.
randomized, double-blind, placebo-controlled 7. Daratumumab Combinations
trials: VIALE-A (NCT02993523) and VIALE-C On August 20, carfilzomib (Kyprolis) and
(NCT03069352). daratumumab (Darzalex) in combination with
5. Nivolumab/Ipilimumab and Nivolumab dexamethasone was approved for adult patients
Alone with relapsed or refractory multiple myeloma who
On October 2, nivolumab (Opdivo) plus have received one to three lines of therapy.
ipilimumab (Yervoy) was approved as first-line Approval was based on findings from -CANDOR
treatment for adult patients with unresectable (NCT03158688), a randomized, open-label,
malignant pleural mesothelioma. Approval was multicenter trial. On May 1, a fixed combination of
based on findings from CheckMate 743 daratumumab and hyaluronidase-fihj (Darzalex
(NCT02899299), a randomized, open-label trial.On Faspro) was approved for adult patients with newly
June 10, nivolumab monotherapy was approved for diagnosed or relapsed/refractory multiple myeloma.
patients with unresectable advanced, recurrent, or Approval was based on COLUMBA
metastatic esophageal squamous cell carcinoma (NCT03277105), an open-label noninferiority trial.
after prior fluoropyrimidine- and platinum-based 8. Belantamab Mafodotin-blmf
chemotherapy. Approval was based on On August 5, belantamab mafodotin-blmf
ATTRACTION-3 (NCT02569242), a multicenter, (Blenrep) was approved for adult patients with
randomized, active-controlled, open-label trial. On relapsed or refractory multiple myeloma who have
May 26, nivolumab plus ipilimumab and two received at least four prior therapies, including an
cycles of platinum-doublet chemotherapy was anti-CD38 monoclonal antibody, a proteasome
approved as first-line treatment of patients with inhibitor, and an immunomodulatory agent.
metastatic or recurrent NSCLC, with no EGFR or Approval was based on findings from DREAMM-2
ALK genomic tumor aberrations. Approval in this (NCT 03525678), an open-label, multicenter trial.

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9. Tafasitamab-cxix explicit Cytotoxicity to the malignancy cells is

On July 31, accelerated approval was medications of decision.
granted to tafasitamab-cxix (Monjuvi), a CD19-
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