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Merck's Keytruda sBLAs for 6-Week Dosing to be Reviewed by FDA

Zacks Equity Research

Merck & Co., Inc. MRK announced that the FDA has accepted for review its supplemental Biologics License Applications (sBLAs) looking for approval of an improved dosing schedule of its blockbuster anti-PD-1 therapy, Keytruda.

Merck is looking for approval of a six-week 400 mg dosing option of Keytruda for six indications —melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma. The new recommended dose will be delivered as an intravenous infusion over 30 minutes and will provide greater flexibility than the currently approved dose of 200 mg every three weeks infused over 30 minutes. The FDA will give its decision on Feb 18, 2020.

In March, the European Commission had approved the 400 mg six-week dosing schedule of Keytruda for approved monotherapy indications in EU.

Merck’s stock has risen 11% this year so far compared with a 1.9% increase for the industry.



Keytruda, Merck’s biggest product, is approved for use in 15 cancer indications across 10 different tumor types in the United States.

Keytruda generated sales of $2.27 billion in the first quarter of 2019, up around 5.6% sequentially and 55% year over year. Sales were driven by the launch of indications globally. Keytruda sales are gaining particularly from strong momentum in first-line lung cancer indication both as monotherapy and with the rollout of the chemotherapy combo in both non-squamous and squamous NSCLC.

This year so far, Keytruda has gained several label expansion approvals. Keytruda was approved by the FDA as an adjuvant therapy for high-risk stage III melanoma and for five new cancer line extensions in Japan in the first quarter. In April, the FDA gave approval to Keytruda in combination with Pfizer’s PFE Inlyta for the first-line treatment of advanced renal cell carcinoma as well as for an expanded first-line lung cancer patient population. In June, Keytruda was approved by the FDA for first-line treatment of recurrent or metastatic HNSCC and for previously treated advanced small-cell lung cancer (SCLC). All these label expansion approvals should drive sales of Keytruda higher in the future quarters.

The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1000 studies, including more than 600 combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte INCY, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.

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

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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