The U.S. Food and Drug Administration (FDA) will review BioLineRx’s application to approve Aphexda, formerly known as motixafortide, as an add-on stem cell mobilization therapy to improve stem cell transplants in people with multiple myeloma. The decision comes about two months after the company submitted a…
The efficacy and safety of Blenrep (belantamab mafodotin) as a treatment for relapsed/refractory multiple myeloma (RRMM) in a real-world setting is similar to what has been reported in clinical trials, according to a study from Israel. “Response rate, duration of response and toxicity profile appear to be comparable to…
Janssen’s Tecvayli (teclistamab) has been approved for certain adults with relapsed or refractory multiple myeloma in the U.S., but access is limited due to potential side effects. In particular, the approval by the U.S. Food and Drug Administration (FDA) is for patients who have received at least four…
The first patient has been dosed in Ichnos Sciences’ Phase 1/2 clinical trial investigating ISB 1442, an experimental bi-specific antibody treatment for people with relapsed or refractory multiple myeloma. ISB 1442 targets two proteins on cancer cells, CD47 and CD38, and also binds to immune cells. These simultaneous…
A new investigational CAR T-cell therapy, called MCARH109, demonstrated an ability to shrink or eliminate the amount of cancer in patients with relapsed or refractory multiple myeloma, according to results from a dose-escalation Phase 1 trial. Safety findings showed the treatment at its highest dose was not safe for…
The International Myeloma Foundation’s (IMF) M-Power project, which seeks to improve disease outcomes for African Americans with multiple myeloma, has formed a partnership with yet another U.S. city, this time New York. Myeloma is the most common blood cancer among Black Americans, who have an above-average risk of the…
An advisory panel to the U.S. Food and Drug Administration (FDA) has overwhelmingly decided that the Phase 3 OCEAN clinical trial did not provide sufficient evidence to support Pepaxto (melphalan flufenamide) as a treatment for relapsed or refractory multiple myeloma (RRMM). Notably, while the FDA will consider the committee’s…
An upcoming clinical trial will evaluate the CAR T-cell therapy Abecma (idecabtagene vicleucel) in people newly diagnosed with multiple myeloma who had a suboptimal response to a standard stem cell transplant. Additional information about the KarMMa-9 trial, including its design and timing, will come at the earliest opportunity,…
For this Blood Cancer Awareness Month, observed each September, the International Myeloma Foundation (IMF) is focusing on educating people about multiple myeloma, the second most common type of blood cancer. The month is set aside to heighten awareness about all blood cancers, which are diagnosed every three minutes…
The European Commission has approved Pepaxti (melphalan flufenamide, also called melflufen), a medicine by Oncopeptides to be used in combination with dexamethasone, making it available to adults with hard-to-treat multiple myeloma in Europe. The approval came after the Committee for Medicinal Products for Human Use, an arm of…
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