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Pharmacological Profile of Novel Anti-cancer Drugs Approved by USFDA in 2022: A Review.

作者信息

Sangwan Kavita, Sharma Vipasha, Goyal Parveen Kumar

机构信息

Department of Pharmacy, Panipat Institute of Engineering and Technology (PIET), Samalkha, Panipat, 132102, Haryana, India.

出版信息

Curr Mol Med. 2024;24(6):734-750. doi: 10.2174/1566524023666230622151034.


DOI:10.2174/1566524023666230622151034
PMID:37350009
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 (Lu)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.

摘要

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[1]
Retifanlimab: First Approval.

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[2]
Landscapes and mechanisms of CD8 T cell exhaustion in gastrointestinal cancer.

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[3]
Selective Estrogen receptor degraders (SERDs) for the treatment of breast cancer: An overview.

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[4]
Elacestrant: First Approval.

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[5]
Pirtobrutinib: First Approval.

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[6]
Olutasidenib: First Approval.

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[7]
PSMA-Targeted Radiopharmaceuticals in Prostate Cancer: Current Data and New Trials.

Oncologist. 2023-5-8

[8]
Adagrasib: First Approval.

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[9]
Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study.

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[10]
End-to-end approach for the characterization and control of product-related impurities in T cell bispecific antibody preparations.

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