Merck & Co., Inc. MRK announced that the FDA has granted priority review to yet another supplemental biologics license application (sBLA) for its PD-L1 inhibitor, Keytruda. In the latest sBLA, Merck is looking for FDA’s approval of Keytruda as monotherapy for advanced small cell lung cancer ("SCLC") in third or later-line setting. With the FDA granting priority review, a decision is expected on Jun 17, 2019.

The sBLA filing was based on data fromthe SCLC cohorts of the phase II KEYNOTE-158 study as well as supporting data from an early stage study — KEYNOTE-028. Data from the KEYNOTE-158 study, presented in June 2018, showed that treatment with Keytruda achieved overall response rate of 18.7% with 3% complete response in patients whose disease progressed after two or more lines of prior therapy. The median progression free survival was 2 months and median overall survival was 8.7 months.

The KEYNOTE-158 study is a multi-cohort study evaluating Keytruda in several indications. Last year, the drug was approved for treating advanced cervical cancer in second-line setting based on the data from a cohort of this study.

The company is also evaluating Keytruda in combination with chemotherapy in a late-stage study, KEYNOTE-604, for treating newly diagnosed extensive stage SCLC.

In the past six months, Merck’s shares have outperformed the industry, rising 15% compared with a 1.5% increase for the industry.

The sBLA is the first regulatory application seeking approval of Keytruda in the difficult-to-treat cancer, SCLC, in any setting. It is also the third sBLA to get priority review from the FDA this month. Earlier this month, Merck announced that the FDA has granted priority review to its label expansion regulatory applications looking for approval of Keytruda as first-line treatment for recurrent or metastatic head-and-neck squamous cell carcinoma (“HNSCC”) and advanced or metastatic renal cell carcinoma (“RCC”).

Keytruda has been the biggest revenue generator for Merck in 2018 and also a key contributor to the company’s sales growth in the last few years. Keytruda is continuously growing and expanding into new indications and markets globally. It is already approved for use in 15 indications across 10 different tumor types in the United States. The drug generated sales of $7.17 billion in 2018, recording growth of 88% year over year.

Keytruda already commands a strong position in the non-small cell lung cancer (“NSCLC”) segment as it is the only anti-PD-1 approved in first-line setting for NSCLC. An approval for treating SCLC will further strengthen Keytruda’s position in the lung cancer market.

Merck is also progressing well with the Keytruda development program. The drug is being studied for more than 30 types of cancer in more than 900 studies, including more than 500 combination studies. Merck has collaborated with several companies including Amgen AMGN, Incyte INCY, Glaxo GSK and Pfizer separately for the evaluation of Keytruda in combination with other regimens.

We believe that Keytruda has strong growth prospects based on increased utilization, approval for new indications and expectation of additional approvals worldwide.

Merck & Co., Inc. Price

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