LILLY SCORES ONCOLOGY TRIFECTA WITH RETEVMO FDA APPROVAL
Eli Lilly’s acquisition of Loxo Oncology pays off
Eli Lilly’s (NYSE: LLY) Retevmo (selpercatinib) has earned FDA approval. Retevmo was designated as a breakthrough therapy and evaluated according to the FDA’s priority review process. It is indicated for the:
- Treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
- Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
- Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
Retevmo is a selective RET kinase inhibitor
Retevemo is available by prescription only and produced in 40mg and 80mg capsule strengths. It targets the RET gene that provides instructions for producing proteins involved with signaling within cells. It selectively binds to and inhibits the activity of RET as RET overexpression, activating mutations and fusions trigger the upregulation and/or overactivation of RET tyrosine kinase activity in various cancer cell types. The dysregulation of RET activity plays a key role in the development and progression of various types of cancers.
Three FDA-approved indications is a win for cancer patients, oncologists and Lilly
Retevmo’s 3 FDA-approved indications provide oncologists with a triple-threat to treat more patients. Its oral formulation is a plus to avoid costly and inconvenient IV administration and the two capsule strengths provide flexibility in dosing for clinicians. All of these attributes benefit patients and the oncology medical community that are always seeking more and better cancer treatment options.
The three indications also provide improved market access for Retevmo. Lilly will be able to position the product more effectively on managed care organization (MCO) and pharmacy benefit management (PBM) formularies as well as with specialty pharmacy providers.
Lilly cashing in its multi-billion purchase of Loxo -will Pfizer benefit as well?
In 2019 Lilly acquired Loxo Oncology for $8 billion. Lilly’s strategic acquisition of Loxo was based on Loxo’s highly focused research efforts aligned with advanced therapeutics for genomically defined cancers. Loxo was headquartered in Stamford, Connecticut.
Loxo initiated the development and commercialization of Retevmo by acquiring it and its other FDA approved oncology drug, Vitrakvi (larotrectinib), from Array Biopharma. The deal included royalties on presumptive global net sales of the pipeline candidates following approval by regulators and subsequent market launches. How those royalties will be issued moving forward is an interesting consideration as Array Biopharma was acquired by Pfizer in 2019 for about $10.6 billion.
Lilly is a growing contender in the development of novel cancer treatments
Lilly, based in Indianapolis, Indiana, was founded in 1876 and generates about $22.3 billion in annual sales. The pair of complex therapies, Vitrakvi and Retevmo, plus other pipeline candidates from the Loxo Oncology acquisition enriches the Lilly cancer treatment portfolio that includes Alimta (pemetrexed) and Cyramza (ramucirumab). They position Lilly as a viable competitor and innovator with other leading oncology companies such as Bristol Myers Squibb, GSK, Merck, Novartis, Roche and Seattle Genetics.
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