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Merck’s (MRK) Keytruda Gets FDA Approval for Cervical Cancer

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Merck MRK has received FDA’s accelerated approval for label expansion of its blockbuster anti-PD-1 therapy, Keytruda, to include advanced cervical cancer in second-line setting. The company will need to evaluate the drug in confirmatory studies in this indication for gaining continued approval.

The eligible patients for the treatment in cervical cancer will be selected based on an FDA-approved test for PD-L1 expression in tumors with combined positive score (“CPS”) ≥1.

The approval comes a bit earlier than the expected date of Jun 28. The FDA had granted priority review to this label expansion regulatory application in March.

Keytruda is the most successful immuno-oncology drug to date with approval in several cancer indications including the lucrative first-line lung cancer. This is the first anti-PD-1 therapy approved in advanced cervical cancer and the first indication for Keytruda in gynecologic cancer as well.


This year so far, Merck’s shares have outperformed the industry. Its shares have risen 10.9% in the period against the industry’s decline of 4.4%.

The latest FDA approval is based on data from a single cohort of a multi-cohort phase II study – KEYNOTE-158 – evaluating the drug in recurrent or metastatic cervical cancer. Data from a subset of patient population expressing PD-L1 with a CPS ≥1 showed that Keytruda achieved an objective response rate of 14.3%. Moreover, 2.6% of the patients achieved a complete response and 11.7% of patients demonstrated partial response.

The drug generated no response in cervical cancer patients whose PD-L1 expression in tumors had a CPS <1.

Merck is evaluating the drug in a wide range of cancer indications and treatment settings in more than 750 clinical studies.

At the recently concluded annual meeting of the American Society of Clinical Oncology, this PD-L1 inhibitor stole the limelight with encouraging data from multiple clinical studies. The data presentation, which garnered attention from physicians and investors, was from a second interim analysis of a pivotal lung cancer study on Keytruda — phase III KEYNOTE-407 study.

Moreover, Merck has collaborated with several pharma companies, including Amgen AMGN, Glaxo GSK, Pfizer PFE and Incyte, to evaluate Keytruda in combination with other regimens.

The drug generated worldwide sales of almost $1.5 billion in the first quarter of 2018, up 150% from the year-ago period. With this line extension approval in cervical cancer and potential approvals in other indications under review, the positive momentum of the drug is expected to continue in 2018.

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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