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Merck's (MRK) Breast Cancer sBLA for Keytruda Gets CRL (Revised)

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Merck MRK announced that the FDA has issued a complete response letter (“CRL”) to its supplemental Biologics License Application (sBLA) for its multi-cancer drug, Keytruda. The sBLA was seeking label expansion of the drug as neoadjuvant and adjuvant treatment for patients with high-risk early-stage triple-negative breast cancer (TNBC). The company was seeking a combination of Keytruda with chemotherapy for neoadjuvant treatment, followed by Keytruda monotherapy for adjuvant treatment after surgery.

The sBLA was filed based on data on pathologic complete response (pCR)and early interim event-free survival from the ongoing phase III study — KEYNOTE-522. Recently, the FDA’s Oncologic Drugs Advisory Committee voted for deferral of regulatory decision on the TNBC sBLA for Keytruda until further data are available from the late-stage study. The company is reviewing the CRL and will discuss future regulatory steps for the sBLA.

We note that the next interim-analysis of the study will occur in the third quarter of 2021. The issuance of the CRL by the FDA is likely due to unavailability of sufficient data. We assume a potential approval for Keytruda in TNBC indication will come after the next interim-analysis.

Among different cancers, Keytruda is already approved in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic TNBC patients with tumors expressing PD-L1. However, the recent CRL will have no impact on this indication as well as other approved indications.

Shares of Merck have lost 4.3% so far this year against the industry’s increase of 0.7%.

We note that Keytruda, which is Merck’s major revenue-generating product, is already approved for use in 26 indications across 16 different tumor types and certain tumor agnostic indications. The drug recorded sales of $14.4 billion in 2020, up 30% year over year. Keytruda sales have been gaining momentum through constant label expansion and the launch of new indications globally.

The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being evaluated in more than 1400 studies including several combination studies. Merck has collaborated with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE, separately, for the evaluation of Keytruda in combination with other regimens.

Merck & Co., Inc. Price

Merck & Co., Inc. Price
Merck & Co., Inc. Price

Merck & Co., Inc. price | Merck & Co., Inc. Quote

Zacks Rank

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

(We are reissuing this article to correct a mistake. The original article, issued on March 30, 2021, should no longer be relied upon.)


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