Much of the biopharmaceutical world is abuzz right now thanks to the whirlwind of presentations at the American Society of Clinical Oncology (ASCO) meeting over the last few days. As always, some biotechs emerge as winners in the eyes of investors after announcing great results from clinical studies.
But as encouraging as positive clinical results might be, there’s still nothing like actually winning FDA approval for an important drug. Three companies that are on track to score major FDA approvals in June are…
Merck hopes to gain two additional approved indications for its blockbuster cancer drug Keytruda this month. The FDA set a PDUFA date of June 10, 2019, for making a decision on Keytruda as a monotherapy or in combination with chemotherapy as a first-line treatment of head and neck squamous cell carcinoma (HNSCC).
The FDA is scheduled to announce another approval decision for Keytruda by June 17. Merck is looking to win approval for its top-selling drug as a third-line treatment for small cell lung cancer (SCLC). This is the first SCLC approval that the company has sought for Keytruda, which is already a leader in treating non-small cell lung cancer (NSCLC).
Both FDA decisions are important for Merck. Keytruda remains the top growth driver for the company, and additional indications are key to Merck’s long-term strategy. The big pharma company recently experienced a setback with that strategy, though. In May, Merck announced that Keytruda had failed in a late-stage clinical study in previously treated triple-negative breast cancer.
2. AMAG Pharmaceuticals
AMAG Pharmaceuticals awaits an FDA decision that’s more critical to the company than the approval decisions on Keytruda are for Merck. The FDA should hand down its verdict on Vyleesi in treating hypoactive sexual desire disorder (HSDD) in premenopausal women by June 23.
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