- News follows backlash for GSK’s blood cancer drug Blenrep
- Shares fall nearly 5% in afternoon trade
NOVEMBER 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 treatment option to keep cancer at bay in patients whose tumors carry certain mutations.
The news marks a second setback for GSK’s oncology portfolio this week, after the company announced on Monday that its blood cancer drug Blenrep had failed to outperform an older therapy in a pivotal study, calling into question Blenrep’s existing US approval asked.
Shares of the drugmaker are down almost 5% as of Friday afternoon.
Zejula belongs to a family of drugs called PARP inhibitors — which includes 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 drawbacks, prompting their manufacturers to limit their use in ovarian cancer patients after clinical data suggested patients in “later treatment settings” are not living as long as those receiving chemotherapy, i.e. patients who are were initially treated with other drugs.
In September, GSK stopped using Zejula in certain patients with ovarian cancer who had received three or more prior chemotherapy regimens.
The move came in consultation with the U.S. Food and Drug Administration (FDA) and in line with data across the broader class of therapies that indicated the drugs could have an adverse effect on survival rates in such patients, the said Company.
It soon transpired that in November FDA advisors wanted to consider whether the use of Zejula in second-line therapy was warranted given the emergence of additional survival data from a pivotal study.
Zejula received FDA approval in 2017 for use in second-line therapy — as a therapy to keep cancer at bay in patients who already had recurrence of epithelial ovarian, fallopian tube, or primary peritoneal cancer but had a complete or partial response tumor to platinum-based chemotherapy.
But the November 22 FDA meeting was canceled in late October. On Friday, GSK announced that it has 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 carrying certain mutations.
For GSK, the use of Zejula in first-line therapy – as a cancer control therapy in ovarian cancer patients who have partially or fully benefited from platinum-based chemotherapy – remains a priority.
About 25% of Zejula’s U.S. sales came from the second-line indication – prior to the imposition of this latest restriction – a GSK spokesman told Reuters, adding that there is no change to Zejula’s second-line indication outside of the United States .
Zejula – which GSK acquired in 2018 by acquiring US cancer specialist Tesaro for $5.1 billion – generated a total of £120 million ($141.4 million) in the most recent quarter.
Barclays has forecast annual peak sales of £697m for the drug in 2026, leading analyst Emily Field to believe sales will 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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