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FDA Approves Expanded Use Of GSK's Ovarian Cancer Drug Zejula

zejula oct24 lt

The FDA has approved GlaxoSmithKline plc's (GSK) ovarian cancer drug ZEJULA for an additional indication.

The new indication is for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either:

-- BRCA mutation or Homologous recombination deficiency (HRD) and have progressed more than six months after the last platinum-based chemotherapy.

Myriad Genetics Inc.'s (MYGN) myChoice CDx for use as a companion diagnostic by healthcare professionals to identify women with advanced ovarian cancer who are candidates for Zejula in the late-line treatment setting has also secured the FDA approval. The regulatory nod marks the first FDA-approval for myChoice CDx, which is the only FDA-approved tumor test for this indication.

ZEJULA received its initial approval in March 2017, for the maintenance treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer regardless of BRCA mutation or biomarker status.

Developed by US-based biopharmaceutical company Tesaro, ZEJULA came under GlaxoSmithKline's fold when the former was acquired in December 2018. The drug is approved in 36 countries and launched in the U.S., Germany, UK, and Italy.

After coming under the aegis of GlaxoSmithKline, sales of the drug were 42 million Euros in Q1, 2019, and 57 million Euros in Q2, 2019.

GSK closed Wednesday's trading at $43.27, up 1.76%.

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