Who doesn’t love a comeback story? Certainly not GSK, which has found a way to resuscitate its cancer treatment Blenrep as a combo agent after it was pulled from the U.S. market as a monotherapy in late 2022.
This week, Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended Blenrep for approval for patients with relapsed or refractory multiple myeloma.
The CHMP has given Blenrep a thumbs-up in two combinations for patients who have received at least one prior therapy including Bristol Myers Squibb’s Revlimid (lenalidomide). One combo pairs Blenrep with the protease inhibitor Velcade (bortezomib) plus the corticosteroid dexamethasone. The other regimen includes Blenrep with BMS's Pomalyst (pomalidomide) and dexamethasone.
In 2020, the FDA signed off on the antibody-drug conjugate as a monotherapy for patients who had tried at least four other treatments, but two years later, Blenrep came up short in a confirmatory trial.
Since then, Blenrep has emerged victorious in two phase 3 trials, topping standard of care as a combo agent. In both trials, the Blenrep regimen showed a statistically significant and clinically meaningful edge in improving patients' progression-free survival.
Last month, Blenrep earned an approval in the U.K. Then earlier this week, officials in Japan endorsed the GSK regimen. The FDA has a target date of July 23 to decide on the Blenrep combo.
Novartis pulls Lutathera request
Meanwhile, Novartis’ bid to expand the label of its radiotherapy Lutathera in Europe is on hold after the company withdrew its filing, according to the CHMP.
The committee explained that Novartis made the decision after “there were still some unresolved issues,” after the company answered a round of questions about the application, which was backed by a trial of 226 patients.
The CHMP said that while the study found that Lutathera increased the amount of time patients lived without disease progression, “its impact on extending patients’ lives had not been established.” The committee concluded that the benefits of the treatment did not outweigh the risks.
Lutathera has been on the market for eight years as a treatment for rare cancers of the digestive tract. The company had been seeking approval for Lutathera to treat adults with newly diagnosed unresectable or metastatic, well-differentiated high-grade somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
Other CHMP decisions
The CHMP also signed off on Autolus Therapeutics’ Aucatzyl as a treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The FDA endorsed Aucatzyl in the indication in November of last year.
Also making the grade at this week's CHMP meeting was SpringWorks Therapeutics’ MEK inhibitor Ezmekly for patients with symptomatic, inoperable neurofibromatosis type 1–associated plexiform neurofibromas (NF1-PN), which lead to tumor growth inside and along the nerves. The recommendation follows a February approval for the treatment in the U.S., where it goes by the commercial name of Gomekli.
The CHMP also blessed Roche’s Itovebi as a combo treatment with palbociclib and fulvestrant as a first-line regimen for PIK3CA-mutated, estrogen-receptor (ER)-positive, HER2-negative locally advanced and metastatic breast cancer. The combo scored a nod from the FDA in October of last year.
Receiving a thumbs-down from the CHMP were 4SC’s Kinselby, for the treatment of advanced stage mycosis fungoides and Sezary syndrome, and Fresenius Kabi’s Atropine sulfate for children with myopia.