Lilly's NDA for Selpercatinib Gets FDA's Priority Review

Eli Lilly and Company LLY announced that the FDA has granted priority review to its new drug application (NDA) for selpercatinib (LOXO-292), an oral RET inhibitor. The NDA is seeking approval of selpercatinib for treating advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

The FDA is expected to announce its decision in the third quarter of 2020.

Notably, selpercatinib was added to Lilly’s portfolio with the February 2019 acquisition of Loxo Oncology, which broadened its scope in precision medicines. If approved, selpercatinib will provide a new precision therapy for patients living with certain RET-driven cancers.

The FDA generally grants a priority review to drugs with potential to treat a serious condition and if approved, would substantially improve safety or effectiveness.

The NDA was based on data from the phase I/II LIBRETTO-001 study, which evaluated selpercatinib for RET-altered lung and thyroid cancers. In September 2019, Lilly announced positive results from the above-mentioned study.

Later in December, Lilly began two other phase III studies on selpercatinib. While the LIBRETTO-431 study evaluated selpercatinib for treating patients with treatment-naïve RET fusion-positive NSCLC, the LIBRETTO-531 study investigated the same for addressing patients with treatment-naïve RET-mutant MTC. Both studies are looking to enroll 400 patients.

Shares of Lilly have rallied 16.7% in the past year compared with the industry’s increase of 12.1%.

Precision medicines are an emerging approach to cancer treatment, which tailors a regime depending on the patient’s genetic, environmental and lifestyle factors. Many industry players are adopting this method to bring new cancer treatments.

One such company is Blueprint Medicines Corp. BPMC, which is developing transformational precision medicines to address patients with genomically defined cancers and rare diseases. The company is developing pralsetinib, an investigational precision therapy, to address the RET fusion-positive NSCLC and RET-mutant MTC. The company plans to complete the NDA submission for pralsetinib in the first quarter of 2020 to treat NSCLC while the same for the MTC indication is expected to be filed in the second quarter.

Zacks Rank & Other Stocks to Consider

Lilly currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the large cap pharma sector include Roche Holding AG RHHBY and Sanofi SNY, both carrying a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Roche’s earnings estimates have moved 1.9% north for 2020 over the past 60 days. The stock has soared 24.6% in the past year.

Sanofi’s earnings estimates have been revised 1.5% upward for 2020 over the past 60 days. The stock has jumped 12.3% in the past year.

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