China’s National Medical Products Administration (NMPA) has conditionally approved a combination of Xpovio (selinexor) and the corticosteroid dexamethasone to treat adults with relapsed or refractory multiple myeloma (RRMM) who received at least three prior therapies. This includes patients whose disease failed to respond to at least one immunomodulatory agent (IMiD), one proteasome inhibitor (PI), and…
Janssen has submitted an application to regulators in Japan seeking the approval of ciltacabtagene autoleucel, an investigational CAR T-cell therapy also known as cilta-cel, to treat relapsed or refractory multiple myeloma patients. The submission to the Japanese Ministry of Health, Labour and Welfare (MHLW) specifically asks that cilta-cel be approval for patients who received at…
The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase), in combination with Kyprolis (carfilzomib) and the corticosteroid dexamethasone, for the treatment of adults with multiple myeloma who have received one to three lines of therapy. Darzalex Faspro is a subcutaneous, or under-the-skin, formulation of the Janssen laboratory-made therapy Darzalex (daratumumab),…
Gracell Biotechnologies’ investigational new treatment for multiple myeloma, GC012F, has been named an orphan drug by the U.S. Food and Drug Administration (FDA). Orphan drug status is intended to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. It provides benefits and incentives, including exemption from FDA application…
Biohaven Pharmaceuticals has begun enrolling patients in its Phase 1a/1b trial testing the company’s antibody-recruiting molecule (ARM) called BHV-1100. The trial (NCT04634435) seeks to recruit 25 adults with newly diagnosed multiple myeloma who have minimal residual disease in first remission before a stem cell transplant. One patient has now been enrolled. The trial will assess…
The optimal dosing of tasquinimod, Active Biotech’s experimental oral therapy for adults with relapsed or refractory multiple myeloma, has been determined in a Phase 1b/2a clinical trial. Now, that dose and schedule will be tested, along with the standard oral combination treatment, in the trial’s second phase, the company said in a press release. “We…
After promising early results, a sub-study of the DREAMM-5 platform trial is moving forward to its next phase to test a combination of Blenrep (belantamab mafodotin) with nirogacestat in adults with relapsed or refractory multiple myeloma. In addition, two sub-studies will be added to the trial (NCT04126200), sponsored by Blenrep developer GlaxoSmithKline (GSK), to evaluate…
The U.S. Food and Drug Administration (FDA) is expected to decide by the end of February whether or not to approve ciltacabtagene autoleucel, known as cilta-cel, an investigational CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. The FDA extended its expected decision date to allow sufficient time to review information about…
After failing to significantly extend survival in a confirmatory Phase 3 trial, Keytruda (pembrolizumab) will no longer be available in the U.S. for people with previously treated metastatic small cell lung cancer (SCLC). According to Merck, known as MSD outside North America, the company decided to voluntary withdraw this indication after consulting with the U.S. Food…
A combination of ilixadencel plus first-line treatment with Sutent (sunitinib) prolonged overall survival to a clinically meaningful extent in newly diagnosed patients with metastatic renal cell carcinoma (mRCC), a form of kidney cancer, a Phase 2 trial found. People given this combo treatment in the MERECA trial (NCT02432846) lived 10 months longer than those on Sutent…
