GlaxoSmithKline plc GSK announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending the approval of its PARP inhibitor Zejula (niraparib) as a monotherapy for the first-line maintenance treatment of women with platinum-responsive ovarian cancer regardless of the BRCA mutational status.
The European Commission will make its decision in a few months. If approved, the label expansion will significantly expand Zejula’s eligible ovarian cancer patient population in Europe.
The CHMP opinion was based on data from the phase III PRIMA study which evaluated Zejula in women with newly diagnosed advanced ovarian cancer who responded to first-line treatment with platinum-based chemotherapy. Data from the study showed that treatment with Zejula led to a clinically meaningful progression-free survival in the above patient population.
Notably, the FDA approved Zejula for a similar patient population in April 2020.
Glaxo claims that Zejula is the first PARP inhibitor to achieve significant improvement in PFS as a monotherapy in the first-line maintenance setting for ovarian cancer patients, a population which currently has a high unmet medical need and limited treatment options available.
Zejula is currently approved as a maintenance treatment for women with recurrent ovarian cancer who responded to platinum-based chemotherapy regardless of the biomarker status. The same was approved as a treatment for women with advanced ovarian cancer following three or more chemotherapy regimens in October last year.
Shares of Glaxo have declined 16.4% so far this year against the industry’s increase of 1.8%.
Notably, Zejula was added to Glaxo’s portfolio post the acquisition of Tesaro in January 2019. The drug generated sales worth £158 million in the first six months of 2020, reflecting an increase of 58% year over year. The label expansion in the first-line maintenance setting significantly expanded Zejula’s eligible ovarian cancer patient population.
Meanwhile, Zejula is being evaluated for additional ovarian cancer stages as well as for non-small cell lung cancer and breast cancer. A phase III study on first-line NSCLC is expected to begin later this year.
However, competition remains stiff for Zejula. Other FDA-approved PARP inhibitors available in the market are AstraZeneca AZN/Merck’s MRK Lynparza, Clovis Oncology’s CLVS Rubraca and Pfizer’s Talzenna.
Glaxo 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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