In order to prevent cancer in patients whose tumors carry specific mutations, the British company GSK announced that it would restrict the use of its ovarian cancer drug Zejula in the United States as a second line of defense.
The news represents the second setback this week for GSK's oncology portfolio after the company disclosed on Monday that its blood cancer drug Blenrep's current U.S. approval was in jeopardy after failing to outperform an older therapy in a crucial study.
On Friday afternoon, shares of the pharmaceutical company fell by close to 5%.
Zejula is a member of the class of medications known as PARP inhibitors, which also includes Lynparza by AstraZeneca and Merck and Rubraca by Clovis Oncology.
After clinical data suggested that patients did not live as long as those given chemotherapy, in "later-line settings," that is, patients who initially have been treated with other drugs, the makers of the class of therapies were forced to restrict their use in ovarian cancer patients. The class of therapies has been plagued by safety setbacks.
GSK discontinued the use of Zejula in certain ovarian cancer patients who had already received three or more chemotherapy regimens in September.
The company said the decision was made in consultation with the U.S. Food and Drug Administration (FDA) and was supported by data on a broader class of therapies that suggested the drugs might have a negative impact on such patients' survival rates.
Soon after, it was revealed that FDA advisors would examine, in November, whether the use of Zejula in the second-line setting was justified in light of newly released survival data from a significant study.
As a therapy to prevent cancer in patients who have already experienced a recurrence of epithelial ovarian, fallopian tube, or primary peritoneal cancer but have experienced a complete or partial tumor response to platinum-based chemotherapy, Zejula received FDA approval in 2017 for use in the second-line setting.
But in late October, the FDA meeting scheduled for November 22 was postponed. On Friday, GSK announced that it had complied with the FDA's request to limit the use of Zejula as a second-line treatment to only those patients whose tumours have certain mutations or are suspected to have them.
The first-line use of Zejula as a therapy to prevent cancer in ovarian cancer patients who have partially or completely responded to platinum-based chemotherapy is still a top priority for GSK.
Before the implementation of this most recent restriction, the second-line indication for Zejula accounted for about 25% of U.S. sales, a GSK spokesperson told Reuters, adding that the second-line indication for Zejula is unchanged outside of the United States.
Zejula produced a total of 120 million pounds ($141.4 million) in revenue during the most recent quarter. GSK acquired Zejula through its $5.1 billion acquisition of American cancer specialist Tesaro in 2018.
The drug is expected to reach its peak annual sales of 697 million pounds in 2026, according to a forecast from Barclays. Analyst Emily Field projects that sales will then remain flat until 2031, when they will begin to decline.
(Source:www.economictimes.com)
The news represents the second setback this week for GSK's oncology portfolio after the company disclosed on Monday that its blood cancer drug Blenrep's current U.S. approval was in jeopardy after failing to outperform an older therapy in a crucial study.
On Friday afternoon, shares of the pharmaceutical company fell by close to 5%.
Zejula is a member of the class of medications known as PARP inhibitors, which also includes Lynparza by AstraZeneca and Merck and Rubraca by Clovis Oncology.
After clinical data suggested that patients did not live as long as those given chemotherapy, in "later-line settings," that is, patients who initially have been treated with other drugs, the makers of the class of therapies were forced to restrict their use in ovarian cancer patients. The class of therapies has been plagued by safety setbacks.
GSK discontinued the use of Zejula in certain ovarian cancer patients who had already received three or more chemotherapy regimens in September.
The company said the decision was made in consultation with the U.S. Food and Drug Administration (FDA) and was supported by data on a broader class of therapies that suggested the drugs might have a negative impact on such patients' survival rates.
Soon after, it was revealed that FDA advisors would examine, in November, whether the use of Zejula in the second-line setting was justified in light of newly released survival data from a significant study.
As a therapy to prevent cancer in patients who have already experienced a recurrence of epithelial ovarian, fallopian tube, or primary peritoneal cancer but have experienced a complete or partial tumor response to platinum-based chemotherapy, Zejula received FDA approval in 2017 for use in the second-line setting.
But in late October, the FDA meeting scheduled for November 22 was postponed. On Friday, GSK announced that it had complied with the FDA's request to limit the use of Zejula as a second-line treatment to only those patients whose tumours have certain mutations or are suspected to have them.
The first-line use of Zejula as a therapy to prevent cancer in ovarian cancer patients who have partially or completely responded to platinum-based chemotherapy is still a top priority for GSK.
Before the implementation of this most recent restriction, the second-line indication for Zejula accounted for about 25% of U.S. sales, a GSK spokesperson told Reuters, adding that the second-line indication for Zejula is unchanged outside of the United States.
Zejula produced a total of 120 million pounds ($141.4 million) in revenue during the most recent quarter. GSK acquired Zejula through its $5.1 billion acquisition of American cancer specialist Tesaro in 2018.
The drug is expected to reach its peak annual sales of 697 million pounds in 2026, according to a forecast from Barclays. Analyst Emily Field projects that sales will then remain flat until 2031, when they will begin to decline.
(Source:www.economictimes.com)
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