Nov 11 (Reuters) – Britain’s GSK ( GSK.L ) said on Friday it would limit the use of its ovarian cancer drug Zejula in the United States as a second-line treatment to keep bay cancer in patients whose tumors have certain mutations.
The news marks the second blow to GSK’s oncology portfolio this week, after the company revealed on Monday its blood cancer drug Blenrep failed to beat an older therapy in a major study, calling into question the existing US approval of Blenrep.
Shares of the drugmaker fell nearly 5% on Friday afternoon.
Zejula belongs to a family of drugs called PARP inhibitors — which include AstraZeneca’s ( AZN.L ) and Merck’s ( MRK.N ) Lynparza and Clovis Oncology’s ( CLVS.O ) Rubraca.
The class of therapies has been plagued by safety setbacks, prompting their makers to limit their use in ovarian cancer patients, after clinical data suggested patients did not live as long as those given the -chemotherapy, in ‘later settings’, i.e. patients who were initially treated with other drugs.
In September, GSK withdrew the use of Zejula in certain ovarian cancer patients who had previously undergone three or more chemotherapy courses.
The move was in consultation with the US Food and Drug Administration (FDA), and in line with data on the wider class of therapies that indicated the drugs could have a detrimental effect on ir -survival rates in such patients, the company said.
Soon after, it emerged that FDA advisors in November were set to review whether the use of Zejula in the second-line setting was justified, given the emergence of additional survival data from a key study.
SALE ZEJULA
Zejula won FDA approval in 2017 for use in the second-line setting – as therapy to keep cancer at bay in patients who have already had a recurrence of epithelial ovarian, fallopian tube, or peritoneal cancer primary, but had full or partial cancer. tumor response to platinum-based chemotherapy.
But the FDA meeting of November 22 was canceled at the end of October. On Friday, GSK said it complied with the FDA’s request to restrict the use of Zejula as a second-line treatment only in patients whose tumors carry or are suspected of having certain mutations.
For GSK, the use of Zejula in the first-line setting – as a therapy designed to keep cancer at bay in ovarian cancer patients who have partially or fully benefited from chemotherapy based on the platinum, remains a priority.
About 25% of US sales for Zejula came from the second-line indication – before the imposition of this latest restriction – a GSK spokesman told Reuters, adding that there is no change in Zejula’s second-line indication outside the United States.
Zejula – which GSK acquired through its $5.1 billion acquisition of US cancer specialist Tesaro in 2018 – generated a total of 120 million pounds ($141.4 million) last quarter.
Barclays predicted 697 million pounds in peak annual sales for the drug in 2026, after which analyst Emily Field expects sales to remain flat, before starting to decline in 2031.
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Reporting by Natalie Grover in London and Pushkala Aripaka in Bengaluru; editing by Uttaresh.V and Emelia Sithole-Matarise
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