GSK’s oncology portfolio has received a significant boost as its drug Blenrep secures a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The committee has recommended Blenrep for use in combination with the protease inhibitor Velcade (bortezomib) and the corticosteroid dexamethasone for patients with relapsed or refractory multiple myeloma. These patients must have previously undergone at least one treatment regimen, including Bristol Myers Squibb’s Revlimid (lenalidomide).
As noted in the original article, “Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended Blenrep for approval for patients with relapsed or refractory multiple myeloma.”
Blenrep, an antibody-drug conjugate (ADC), was initially granted FDA approval in 2020 as a monotherapy for multiple myeloma patients who had exhausted at least four prior therapies. However, the drug was withdrawn from the U.S. market in late 2022 after failing to meet endpoints in a confirmatory trial. GSK has since repositioned the therapy as a combination regimen.
The drug has shown promise in two phase 3 trials where the Blenrep combo significantly outperformed standard of care, demonstrating statistically significant and clinically meaningful improvements in progression-free survival. “In both trials, the Blenrep regimen showed a statistically significant and clinically meaningful edge in improving patients' progression-free survival,” the article stated.
Recent international regulatory actions support this comeback. The U.K. approved the combination regimen last month, followed by a similar endorsement in Japan earlier this week. The FDA is set to make a decision by July 23.
While GSK celebrates progress, Novartis has opted to withdraw its application to expand the use of its radiotherapy drug Lutathera in Europe. The CHMP confirmed that the decision came after unresolved issues persisted despite Novartis addressing a round of questions related to its application, which was based on a study involving 226 patients.
Although the trial demonstrated improved progression-free survival, the CHMP concluded that the overall survival benefit was unproven. “The committee concluded that the benefits of the treatment did not outweigh the risks,” the article reported. Lutathera has been available for eight years for rare digestive tract cancers. The proposed expansion targeted newly diagnosed adults with unresectable or metastatic, well-differentiated high-grade somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
In other updates from the CHMP meeting, several drugs received favorable opinions:
Conversely, CHMP issued negative opinions on two therapies: 4SC’s Kinselby, intended for advanced mycosis fungoides and Sezary syndrome, and Fresenius Kabi’s Atropine sulfate, developed for pediatric myopia.
