Merck's Keytruda Under FDA Review For Advanced Melanoma

Merck & Co. Inc. (NYSE:MRK) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Keytruda, an anti-PD-1 therapy, for review. The company is seeking approval of the blockbuster drug as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. A decision is expected by Feb 16, 2019.

This year so far, Merck’s shares have outperformed the industry. Its shares have risen 8.5% in the period against the industry’s decline of 4.9%.

The sBLA includes data from pivotal EORTC1325/KEYNOTE-054 study, which demonstrated that Keytruda achieved significant increase in recurrence free survival (“RFS”) after surgery compared to placebo in the patient population. Recurrence free survival was achieved in 75.4% of the patients treated with Keytruda over a year, compared to 61% for placebo. The drug also reduced the risk of disease recurrence or death by 43% over placebo.

Merck has claimed that Keytruda is the first anti-PD1 therapy to achieve RFS benefit in stage IIIA, IIIB and IIIC melanoma patients. The drug has achieved RFS benefit in patients irrespective of BRAF-mutation.

We remind investors that the drug is already approved for seven types of cancer indications in several settings including first-line melanoma and recently approved cervical cancer and large-cell lymphoma. Keytruda garnered sales of $1.5 billion in first-quarter 2018, up 12.9% sequentially and 151% year over year.

Sales of the drug were particularly boosted by the strong momentum in the first-line lung cancer indication. It is the only approved anti-PD-1 therapy as a monotherapy or in combination with Eli Lilly’s (NYSE:LLY) cancer drug, Alimta (pemetrexed) and carboplatin.

Merck is focused on further developing this successful drug in other indications. Keytruda is being evaluated in more than 700 studies, including in excess of 400 combination studies for more than 30 types of cancer. The company has collaborated with several companies including Amgen (NASDAQ:AMGN) , Incyte, Glaxo and Pfizer (NYSE:PFE) separately for the evaluation of Keytruda in combination with other regimens.

Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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