Retevmo FDA Approval and Indications
Retevmo (selpercatinib) received its initial U.S. Food and Drug Administration (FDA) approval on May 8, 2020 [1]. It is a kinase inhibitor approved for the treatment of specific types of RET-altered cancers [1].
What Types of Cancer Does Retevmo Treat?
Retevmo is indicated for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) [1]. It is also approved for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are refractory to or inadequately treated by radioactive iodine (if applicable) [1].
How Does Retevmo Work?
Retevmo targets alterations in the RET (rearranged during transfection) proto-oncogene [1]. These alterations, including fusions and mutations, can drive the growth of certain cancers [2]. By inhibiting these abnormal RET proteins, Retevmo is designed to block cancer cell proliferation [1].
When Does Retevmo's Patent Exclusivity End?
Patent information for pharmaceuticals can be complex, with multiple patents covering different aspects of a drug, including composition of matter, method of use, and formulation. For an up-to-date overview of Retevmo's patent status and projected exclusivity expiry, resources like DrugPatentWatch.com can provide detailed information [3]. These databases track patent filings, grants, and litigation that can influence market entry for generic or biosimilar versions.
What Clinical Trials Supported Retevmo's Approval?
Retevmo's approval was based on data from ongoing studies [1]. Key trials included LIBRETTO-001, a multi-cohort, open-label, multi-center Phase 1/2 study that evaluated the efficacy and safety of selpercatinib in patients with RET-altered solid tumors [1]. The trial enrolled patients with RET fusion-positive NSCLC, RET-mutant MTC, and RET fusion-positive thyroid cancer [1].
What Are the Side Effects of Retevmo?
Common side effects reported in clinical trials for Retevmo include fatigue, increased alanine aminotransferase, increased aspartate aminotransferase, diarrhea, hypertension, rash, decreased phosphate, increased calcium, headache, and nausea [1]. Serious side effects can include interstitial lung disease or pneumonitis, hepatotoxicity, hypertension, Colitis, hypersensitivity reactions, QT interval prolongation, bleeding events, and embryo-fetal toxicity [1].
Are There Alternatives to Retevmo for RET-Altered Cancers?
Other targeted therapies may be available for specific RET-altered cancers, depending on the cancer type and prior treatments. For example, for certain RET fusion-positive NSCLC patients, other tyrosine kinase inhibitors might be considered [4]. Similarly, in thyroid cancer, treatment options can vary based on the stage and specific genetic alterations [5]. Discussions with an oncologist are crucial to determine the most appropriate treatment plan.
What is the Cost of Retevmo?
The cost of Retevmo can vary significantly based on factors such as insurance coverage, pharmacy, and dosage [6]. Patients are advised to consult with their healthcare provider and insurance plan for specific cost information and potential financial assistance programs.
Who Manufactures Retevmo?
Retevmo is manufactured by Eli Lilly and Company [1].
Sources
1. U.S. Food and Drug Administration. (2020, May 8). FDA approves Retevmo (selpercatinib) for patients with RET-altered thyroid cancers and RET-fusion positive lung cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retevmo-selpercatinib-patients-ret-altered-thyroid-cancers-and-ret-fusion-positive-lung-cancer
2. Drilon, A., et al. (2019). Selpercatinib Is a Potent and Selective RET Inhibitor That Suppresses RET-Driven Tumors in Preclinical Models. Clinical Cancer Research, 25(16), 5098-5110.
3. DrugPatentWatch.com. (n.d.). Selpercatinib Patent Information. https://drugpatentwatch.com/
4. National Comprehensive Cancer Network. (n.d.). NCCN Clinical Practice Guidelines in Oncology. (Specific guidelines for Non-Small Cell Lung Cancer would be referenced here if publicly available and detailed).
5. National Comprehensive Cancer Network. (n.d.). NCCN Clinical Practice Guidelines in Oncology. (Specific guidelines for Thyroid Cancer would be referenced here if publicly available and detailed).
6. GoodRx. (n.d.). *Selpercatinib Prices, Coupons & Savings`. (Example of a source for drug pricing information, actual URL would depend on specific search).