About two weeks after European regulators gave their go-ahead for Blenrep (belantamab mafodotin-blmf), the B cell maturation antigen (BCMA)-targeting therapy from Glaxosmithkline plc (GSK) for relapsed/refractory multiple myeloma (MM), the FDA did likewise.
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.
Patients with triple-refractory multiple myeloma who are running out of options may soon have a new lifeline. That’s if the FDA follows the unanimous vote of its Oncologic Drugs Advisory Committee (ODAC) and grants accelerated approval to Glaxosmithkline plc’s (GSK) belantamab mafodotin as a fifth-line therapy for adults with relapsed or refractory multiple myeloma.
Kiadis Pharma NV’s takeover last year of Cytosen Therapeutics Inc. to get a natural killer (NK) platform paid off in a potentially huge way, with Sanofi SA paying €17.5 million (US$19.7 million) up front in a licensing deal with as much as €857.5 million more if preclinical, clinical, regulatory and commercial goals are reached, as well as up to double-digit royalties.
Cellectis SA said the FDA has placed a clinical hold on a phase I study of UCART-CS1A, an allogenic CAR T-cell therapy it has been testing in patients with relapsed or refractory multiple myeloma, after one person enrolled in the study died from a case of treatment-emergent cardiac arrest. Cellectis' chief medical officer, Carrie Brownstein, told BioWorld she supported the move, which formalized a decision she'd already taken with her team.
Nearly a week after filing for a $115 million IPO that it had put off for more than a year, and two months after dosing the first patient in its phase I trial in metastatic castration-resistant prostate cancer, Poseida Therapeutics Inc. has closed on a $110 million series D to continue its CAR T-cell therapy programs.
Oncopeptides AB remains on track for an NDA filing in the second quarter for its peptide-drug conjugate, melflufen, in relapsed refractory multiple myeloma (RRMM).
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. pocketed $60 million in a series funding B round to advance its CT-103A, an anti-BCMA CAR T therapy candidate for multiple myeloma, among other plans.
With new phase III multiple myeloma (MM) data in hand from Newton, Mass.-based Karyopharm Therapeutics Inc.’s Xpovio (selinexor), Wall Street began speculating about what the results might mean in the marketplace.
Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
