Results of a small Phase 2 trial conducted in Switzerland indicate that the HIV treat­ment nelfinavir, in com­bi­na­tion with Velcade and dexa­meth­a­sone, has promising activity in patients with ad­vanced, Velcade-resistant multiple myeloma.

All 34 patients in the Swiss trial had pre­vi­ously been treated with, and stopped responding to, Velcade. All study par­tic­i­pants also were pre­vi­ously treated with Revlimid (lena­lido­mide) and had a median of five over­all prior lines of treat­ment.

In this heavily pre­treated patient group, the com­bi­na­tion of nelfinavir, Velcade, and dexa­meth­a­sone nevertheless achieved at least a partial response in 65 …

• Approval of a More Convenient Once-Weekly Kd70 Regimen Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study
• Application Granted Priority Review Desig­na­tion
• Application Reviewed and Approved Under FDA's Real-Time Oncology Review and Assessment Aid Pilot Programs

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (car­filz­o­mib) to in­clude a once-weekly dosing option in com­bi­na­tion with dexa­meth­a­sone (once-weekly Kd70) for patients with re­lapsed or refractory multiple myeloma. The approval is based on data from the Phase 3 A.R.R.O.W. trial, which dem­onstrated that KYPROLIS admin­istered once-weekly at 70 mg/m² with dexa­meth­a­sone achieved superior pro­gres­sion-free survival (PFS) and over­all …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated the Com­pany’s type II variation appli­ca­tion for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­cluding lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. Validation of the appli­ca­tion con­firms the sub­mission is com­plete and begins the EMA’s centralized review process.

“Given the need for new treat­ment …

• Efficacy and safety con­tinue to be a major ad­van­tage, with a very high response rate, no dose limiting toxicities and only a single in­ci­dence of sus­pected cytokine release syn­drome
• P-BCMA-101 clin­i­cal data as well as pre­clin­i­cal data from MUC1C and PSMA solid tumor pro­grams and BCMA allo­geneic pro­gram presented at the CAR-TCR Summit

San Diego, CA (Press Release) – Poseida Therapeutics Inc. (“Poseida”), a clin­i­cal-stage bio­tech­nology com­pany translating best-in-class gene engi­neer­ing tech­nolo­gies into lifesaving cell ther­a­pies, announced data results from the first eleven patients treated in its ongoing Phase 1 study of its P-BCMA-101 stem cell memory chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) prod­uct in re­lapsed / refractory multiple myeloma. All eleven patients remain on study with seven of ten patients evaluable by Inter­na­tional Myeloma Work­ing Group (IMWG) criteria achieving at least a partial response. The remaining patient also dem­onstrated …

Filing Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study

Thousand Oaks, CA (Press Release) - Amgen (NASDAQ : AMGN ) today announced the sub­mission of a supple­mental New Drug Application (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) to expand the Prescribing Information for KYPROLIS® (car­filz­o­mib) to in­clude a once-weekly dosing option in com­bi­na­tion with dexa­meth­a­sone (Kd) for patients with re­lapsed or refractory multiple myeloma. The sNDA is based on data from the Phase 3 A.R.R.O.W. trial, demonstrating KYPROLIS admin­istered once-weekly at 70 mg/m² with dexa­meth­a­sone (once-weekly Kd) achieved superior pro­gres­sion-free survival (PFS) and over­all response rates (ORR), with a com­parable safety profile versus …

Application based on re­­sults from Phase 2 ELOQUENT-3 study

Princeton, NJ (Press Release) - Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) ac­cepted its supple­mental Biologics License Appli­ca­tion (sBLA) for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. The FDA granted the appli­ca­tion priority review with an action date of De­cem­ber 27, 2018.

“This file ac­ceptance is an im­por­tant step in BMS’s on­go­ing efforts to ad­vance …

Company to Host Conference Call to Discuss Second Quarter 2018 Financial Results and Recent Business Developments on Tuesday, August 7, 2018 at 8:30 a.m. ET

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced the completion of the rolling sub­mission of a New Drug Application (NDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking accelerated approval for selinexor, its novel, oral SINE com­­pound, as a new treat­ment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have pre­vi­ously received the two pro­te­a­some inhibitors (PIs), Velcade® (bor­tez­o­mib) and Kyprolis® (car­filz­o­mib), the two immuno­modu­la­tory drugs (IMiDs), Revlimid® (lena­lido­mide) and Pomalyst® (poma­lido­mide), and the anti-CD38 mono­clonal anti­body Darzalex® (dara­tu­mu­mab) as …