Retevmo (selpercatinib) is a new advanced oncology product from Eli Lilly
Retevmo (selpercatinib) is a new advanced oncology product from Eli Lilly
… Eli Lilly Expands Oncology Therapy Portfolio With FDA Retevmo Approval …


Eli Lilly’s acquisition of Loxo Oncology pays off

John G. Baresky

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

Three FDA-approved indications is a win for cancer patients, oncologists and Lilly

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?

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

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