Bayer AG (BAYRY - Free Report) announced that the FDA has approved Vitrakvi (larotrectinib), the first oral TRK inhibitor. It is approved for the treatment of adult and pediatric patients with solid tumors, with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, which are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR).
Larotrectinib, developed by Bayer and Loxo Oncology, Inc. , is a CNS active TRK inhibitor designed to inhibit these proteins. It will be available in the U.S. market in oral capsules as well as a liquid formulation for adults and children.
The approval is based on data from three studies — the phase I adult study, the phase II NAVIGATE study and the phase I/II pediatric SCOUT study — on patients with TRK-positive tumors. In clinical trials of patients with TRK fusion cancer, larotrectinib demonstrated an overall response rate (ORR) of 75% in 55 evaluable patients, including a 22% complete response (CR) rate. In the studies larotrectinib showed clinical benefit across numerous unique tumor types, including lung, thyroid, melanoma, GIST, colon, soft tissue sarcoma, salivary gland and infantile fibrosarcoma.
In May 2018, larotrectinib was granted Priority Review by the FDA for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion. The FDA previously granted larotrectinib Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation. Bayer submitted a Marketing Authorization Application in the European Union in August 2018. Additional filings in other countries are underway.
The approval bodes well for Bayer and should boost revenues for the company.
The company’s stock has declined 40.2% year to date, against the industry's growth of 10.4%.
Zacks Rank & Stocks to Consider
Bayer has a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks worth considering are Bristol-Myers Squibb Company (BMY - Free Report) and Gilead Sciences Inc. (GILD - Free Report) both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.62 to $3.87 for 2018 and from $3.82 to $4.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 11.99%.
Gilead’s earnings per share estimates have increased from $6.60 to $6.93 for 2018 and from $6.53 to $6.83 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with average of 6.99%.
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