GSK’s Blenrep Recommended by CHMP for Multiple Myeloma Combo Therapy

Highlights

• CHMP recommends GSK’s Blenrep combo regimen for relapsed or refractory multiple myeloma.
• Blenrep repositions after being pulled from the U.S. market as a monotherapy in 2022.
• Novartis withdraws its application to expand Lutathera use in Europe due to unresolved concerns.
• CHMP grants positive opinions for Aucatzyl, Ezmekly (Gomekli), and Itovebi in their respective indications.
• Negative opinions issued for 4SC’s Kinselby and Fresenius Kabi’s Atropine sulfate.

CHMP Endorses Blenrep After Prior Setback

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.”

Path to Redemption After U.S. Withdrawal

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 However, the drug was withdrawn from the U.S. market in late 2022 after failing to meet endpoints in a confirmatory trial.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.

Novartis Withdraws Lutathera Expansion Bid

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).

Additional CHMP Decisions

In other updates from the CHMP meeting, several drugs received favorable opinions:

• Autolus Therapeutics’ Aucatzyl was recommended for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The FDA had previously approved the drug in November.
• SpringWorks Therapeutics’ Ezmekly, a MEK inhibitor for symptomatic, inoperable neurofibromatosis type 1–associated plexiform neurofibromas (NF1-PN), also received CHMP backing. The drug is marketed as Gomekli in the U.S., where it was approved in February.
• Roche’s Itovebi earned a nod as a combination treatment with palbociclib and fulvestrant for first-line use in PIK3CA-mutated, estrogen-receptor (ER)-positive, HER2-negative locally advanced and metastatic breast cancer. The FDA had granted approval in October last year.

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.