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Glaxo Gains First U.S. Approval This Year in Cancer Drug Push

Glaxo Gains First U.S. Approval This Year in Cancer Drug Push

(Bloomberg) -- GlaxoSmithKline Plc’s ovarian cancer drug Zejula won U.S. approval for use at an earlier stage of treatment, giving thousands more patients access to the therapy to help prevent their cancer from coming back.

The U.S. Food and Drug Administration announced the approval Wednesday. The decision further vindicates Glaxo’s $5 billion purchase of Tesaro Inc. in late 2018 -- Zejula was a key product in that deal -- and adds to the competition with AstraZeneca Plc’s cancer drug Lynparza.

The decision is the first of three cancer drug approvals that Glaxo expects this year as Chief Executive Officer Emma Walmsley expands in the lucrative and fast-growing field. The U.K. pharma giant doubled the number of experimental cancer drugs in human testing in search of the next blockbusters.

The FDA’s decision means all women with ovarian cancer can use a so-called PARP inhibitor at the earlier stage of treatment. Previously only those that had a specific genetic mutation known as BRCA -- estimated at about 20% -- were eligible. PARP inhibitors work by hindering a type of protein involved in DNA repair, increasing the likelihood that tumor cells will die rather than repair themselves and continue growing.

“Ovarian cancer is a really difficult-to-treat disease where benefit of existing therapy has been limited,” Axel Hoos, Glaxo’s head of cancer research, said in an interview. “By getting this approval we not only expand the value of the drug for patients we also expand the value for GSK.”

Around 300,000 women are diagnosed with ovarian cancer annually, the majority of whom live in the U.S. The disease will recur in about 85% of cases and is then rarely curable. Glaxo has also applied for approval in Europe, which it’s hoping to get later this year.

Glaxo reported first quarter earnings Wednesday with sales surging 19% to 9.1 billion pounds ($11.3 billion), joining drugmakers whose sales have benefited from patients’ stockpiling ahead of coronavirus lockdowns.

©2020 Bloomberg L.P.