Title:Pharmacological Profile of Novel Anti-cancer Drugs Approved by
USFDA in 2022: A Review
Volume: 24
Issue: 6
Author(s): Kavita Sangwan, Vipasha Sharma and Parveen Kumar Goyal*
Affiliation:
- Department of Pharmacy, Panipat Institute of Engineering and Technology (PIET), Samalkha, Panipat,
132102, Haryana, India
Keywords:
USFDA, Novel anticancer drugs, Krazati, Kimmtrak, Imjudo, Lunsumio, Rezlidhia.
Abstract:
Background: For any drug molecule, it is mandatory to pass the drug
approval process of the concerned regulatory authority, before being marketed. The
Food and Drug Administration (FDA), throughout the year, approves several new drugs
for safety and efficacy. In addition to new drug approvals, FDA also works on improving
access to generic drugs, aimed to lower the cost of drugs for patients and improve
access to treatments. In the year 2022 twelve new drug therapies were approved for
managing varying cancers.
Methods: This manuscript is focused to describe the pharmacological aspects including
therapeutic uses, mechanisms of actions, pharmacokinetics, adverse effects, doses,
indication for special cases, contraindications, etc., of novel FDA-approved anticancer
drug therapies in the year 2022.
Result: FDA has approved about 29% (11 out of 37) novel drug therapies for varying
types of cancers such as lung cancer, breast cancer, prostate cancer, melanoma,
leukemia, etc. The Center for Drug Evaluation and Research CDER has reported that
90% of these anticancer drugs (e.g. Adagrasib, Futibatinib, Mirvetuximabsoravtansinegynx,
Mosunetuzumab-axb, Nivolumab and relatlimab-rmbw, Olutasidenib, Pacritinib,
Tebentafusp-tebn, Teclistamab-cqyv, and Tremelimumab-actl) as orphan drugs and
recommended to treat rare or uncommon cancers such as non-small cell lung cancer,
metastatic intrahepatic cholangio-carcinoma, epithelial ovarian cancer, follicular
lymphoma, metastatic melanoma, metastatic uveal melanoma, etc. CDER has identified
six anticancer drugs (e.g. Lutetium (177Lu)vipivotidetetraxetan, Mirvetuximabsoravtansine-
gynx, Mosunetuzumab-axb, Nivolumab and relatlimab-rmbw, Tebentafusp-tebn,
Teclistamab-cqyv) as first-in-class drugs i.e. drugs having different mechanisms of
action from the already existing ones. The newly approved anticancer drugs shall
provide more efficient treatment options for cancer patients. Three FDA-approved
anticancer drugs in the year 2023 are also briefly described in the manuscript.
Conclusion: This manuscript, describing the pharmacological aspects of eleven
anticancer novel drug therapies approved by the FDA, shall serve as a helpful document
for cancer patients, concerned academicians, researchers, and clinicians, especially
oncologists.