Author Archives: Patricia Inacio PhD

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…

People with advanced multiple myeloma and diffuse large B-cell lymphoma (DLBCL) will soon be able to access Xpovio (selinexor) outside the U.S. through a managed access program. This program, also known as a named patient program, allows patients and doctors in countries where a medicine is not yet approved or…

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Harpoon Therapeutics‘ investigational immunotherapy HPN217 as a possible treatment of multiple myeloma. The designation encourages the development of potential therapies for rare and serious diseases by granting them various financial and regulatory benefits. These include exemptions from…

The U.S. Food and Drug Administration (FDA) has approved a triple combination of Xpovio (selinexor) plus Velcade (bortezomib) and low-dose dexamethasone for the treatment of people with multiple myeloma who received at least one line of therapy. The approval, which comes three months ahead of deadline, was based…

Antengene is asking health authorities in Singapore, Australia, and Hong Kong to approve Xpovio (selinexor) for the treatment of multiple myeloma, the company announced in a press release. Specifically, the new drug applications will cover myeloma patients who have received at least four therapies, and failed to…

Janssen is seeking to extend approval of its under-the-skin formulation of Darzalex (daratumumab) to include its use in combination with Pomalyst (pomalidomide) and dexamethasone to treat relapsed or refractory multiple myeloma patients who received at least one prior line of therapy. The company submitted applications for this combination therapy to…

A recent collaboration between Cytovia Therapeutics and Inserm, the French National Institute of Health and Medical Research, aims to advance new immunotherapies against multiple myeloma based on natural killer cells. Cytovia is developing two distinct therapies for myeloma; one activates and brings these immune cells closer to…

The U.S. Food and Drug Administration has granted fast track designation to PBCAR269A, Precision BioSciences‘ donor-derived CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. Fast track status is meant to facilitate the development, and accelerate the review, of new medications that aim…

The U.S. Food and Drug Administration (FDA) has granted priority review to Oncopeptide’s application seeking accelerated approval of melflufen (melphalan flufenamide) plus dexamethasone for people with relapsed or refractory multiple myeloma (RRMM). The new drug application was submitted in July and based on promising data from…

The first patient has been dosed in a Phase 1/2a trial investigating Precision BioSciences‘ new CAR T-cell therapy candidate, PBCAR269A, for people with relapsed or refractory multiple myeloma. The dose-escalation trial (NCT04171843) is expected to recruit 48 participants at five clinical sites in the U.S. Enrollment…