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    Merck value rises after new Keytruda approval

    Merck’s Wall Street value is climbing after its cancer drug pembrolizumab (Keytruda) received yet another approval from FDA.

    FDA approved Keytruda, at a fixed dose of 200 mg every 3 weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

    Related: Keytruda approved as first-line melanoma treatement

    Keytruda received accelerated approved in October, 2015, to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC). Then, last December, Keytruda received an additional indication from FDA for metastic melanoma after a phase 3 trial found that patients with unresectable or metastatic melanoma who were treated with Keytruda experienced superior overall survival compared to those treated with ipilimumab (Yervoy).

    After the latest approval, Wall Street analysts upped their estimates on Merck earnings. “As Keytruda becomes the gold standard in 1L [first line] disease, prescribers will become much more familiar with it than they are today, creating a positive ‘halo’ effect that should translate into greater Keytruda usage in 2L [second line] disease,” wrote Tim Anderson, analyst with Bernstein & Co., in an investor note.

    Conversely, Bernstein & Co. predicts a sales plunge for Bristol-Myers Squibb, which recently shared a study showing that its cancer drug nivolumab (Opdivo) was no better than standard chemotherapy as first-line therapy in enhancing progression-free survival in advanced NSCLC patients.

    Related: Keytruda for lung cancer gets accelerated approval

    Bernstein & Co. lowered Bristol-Myers Squibb’s sales projections from $13.3 billion to $10.3 billion in 2025. The manufacturer's stock price has plunged since the announcement as well.

    Meanwhile, FDA’s new approval for Keytruda is based on data from the KEYNOTE-012 study, which included patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy or following platinum-containing chemotherapy.

    The data showed an objective response rate (ORR) of 16%, complete response rate of 5%, with responses of 6 months or longer observed in 82% of the responding patients.

    “Head and neck cancer is a complex disease that historically has been associated with high recurrence rates and poor long-term outcomes, highlighting the critical need for new treatment options,” said Dr. Tanguy Seiwert, associate director of the Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago. “The approval of Keytruda for previously-treated patients with recurrent or metastatic head and neck squamous cell carcinoma is an important step forward in treating this disease.”

    Read more: FDA expands Opdivo use for metastatic melanoma

    Christine Blank
    Contributing Editor Christine Blank is a freelance writer based in Florida.


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