- News follow GlaxoSmithKline’s blood cancer drug Blenrep setback
- Shares fell nearly 5% in afternoon trade
Nov 11 (Reuters) – Britain’s GlaxoSmithKline (GSK.L) said on Friday it will limit the use of its ovarian cancer drug Zejula as a second treatment option in the United States to prevent patients whose tumors carry certain mutations get cancer.
The news marks the second setback for GSK’s oncology portfolio this week, after the company revealed on Monday that its blood cancer drug Blenrep had failed to outperform older treatments in a pivotal study, stumbling Blenrep Existing U.S. approvals have been challenged.
Shares of the drugmaker were down nearly 5% on Friday afternoon.
Zejula belongs to a family of drugs called PARP inhibitors, which includes AstraZeneca (AZN.L) and Merck (MRK.N)’s Lynparza and Clovis Oncology (CLVS.O)’s Rubraca.
Such therapies have been plagued by safety setbacks, prompting their manufacturers to limit their use in ovarian cancer patients after clinical data showed that in the “late setting” patients did not live as well as those who received chemotherapy, which was initially treated with chemotherapy. other drug treatments.
In September, GlaxoSmithKline stopped the use of Zejula in certain ovarian cancer patients who had received three or more prior chemotherapy regimens.
The company said the move was made in consultation with the U.S. Food and Drug Administration (FDA) and is consistent with broader treatment data suggesting the drugs may adversely affect survival in such patients.
Before long, FDA advisors will review in November whether Zejula is warranted in a second-line setting, given additional survival data from a pivotal study.
Zejula was approved by the FDA in 2017 for second-line treatment – as a treatment to prevent cancer in patients who already have epithelial ovarian, fallopian tube or primary peritoneal cancer, but who already have tumors in whole or in part Response to platinum-based chemotherapy.
But the 22nd FDA meeting was cancelled in late October in November. On Friday, GlaxoSmithKline said it has complied with the FDA’s request to use Zejula as a second-line treatment only in patients whose tumors carry or are suspected of having certain mutations.
For GlaxoSmithKline (GSK), the use of Zejula in the first-line setting – as a therapy aimed at preventing cancer in ovarian cancer patients who benefit partially or fully from platinum-based chemotherapy – remains a priority.
A GlaxoSmithKline spokesman told Reuters that about 25% of Zele’s U.S. sales came from second-line indications — before this latest restriction was imposed — adding that Zyrara’s second-line indications outside the U.S. no change.
Zejula, acquired by GlaxoSmithKline (GSK) for $5.1 billion in 2018 for U.S. cancer specialist Tesaro, posted total revenue of 120 million pounds ($141.4 million) last quarter.
Barclays expects annual sales of the drug to peak at £697m in 2026, before analyst Emily Field expects sales to be 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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