• DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients
• Today's FDA approval of DARZALEX® in com­bi­na­tion with bortez­o­mib, mel­phalan and pred­ni­sone marks its fifth indi­ca­tion in multiple myeloma

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson an­nounced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) in combi­na­tion with VELCADE® (bor­tez­o­mib)*, a pro­teasome inhibitor (PI); mel­phalan, an alkylat­ing agent; and pred­ni­sone – VMP – for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for autol­o­gous stem cell trans­plant (ASCT). DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients with this disease. Clinical trial results showed DARZALEX® in combi­na­tion with …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• First approval for DARZALEX in a frontline indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Appli­cation (sBLA) for this indi­ca­tion was submitted by Genmab’s licensing part­ner, Janssen Biotech, Inc., in November 2017. The U.S. FDA sub­se­quently granted priority review to the …

• Oral Selinexor Achieves 25.4% Overall Response Rate and Median Duration of Response of 4.4 Months in Patients with Penta-Refractory Myeloma
• Company Plans to Submit a New Drug Application to the FDA in the Second Half of 2018
• Selinexor Continues to Demonstrate a Predictable and Manageable Tolerability Profile
• Management to Host Conference Call Tomorrow, May 1, 2018 at 8:00 a.m. ET

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceutical com­pany, today reported pos­i­tive top-line results from the Phase 2b STORM study eval­u­ating the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound selinexor in heavily pre­treated patients with refractory multiple myeloma. Regarding the STORM study’s pri­mary objective, oral selinexor achieved a 25.4% over­all response rate (ORR), which in­cluded two com­plete responses (CRs) and 29 partial (PRs) or very good …

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track desig­na­tion to the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound selinexor for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy. The FDA’s state­ment, con­sis­tent with the design of Karyopharm’s Phase 2b STORM study, noted that the three prior lines of ther­apy in­clude regi­mens com­prised of an alkylating agent, a gluco­corticoid, Velcade® (bor­tezo­mib), Kyprolis® (car­filz­o­mib), …

San Diego, CA (Press Release) – Sorrento Therapeutics, Inc. (NASDAQ:SRNE) and Celularity Inc announced today that the com­pa­nies have started screen­ing patients for its leading CD38 chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy drug devel­op­ment pro­gram, fol­low­ing FDA review allowing clin­i­cal trial initiation.

The com­pa­nies’ CD38 CAR-T pro­gram is their most ad­vanced pro­gram targeting this dif­fi­cult-to-treat con­di­tion. This trial is cur­rently the only active US-based clin­i­cal trial targeting CD38 using a CAR-T cell ther­apy.

The first inves­ti­ga­tional site at Roger Williams Medical Center, RI, is actively engaged in the clin­i­cal study execution, with …

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of targeted treat­ments for can­cer, an­nounces that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. P150207US03, entitled “Alkylphosphocholine analogs for mul­ti­ple myeloma imaging and ther­apy.” The claims in this pat­ent cover a method of use for CLR 131, the com­pany's pro­pri­e­tary lead Phospholipid Drug Conjugate™ (PDC™) in mul­ti­ple myeloma (MM). Cellectar and the Wisconsin Alumni Research Foundation (WARF) are joint owners of the pat­ent and Cellectar has licensed …

• bluebird and Celgene will share 50% of U.S. costs and profits
• bluebird to re­ceive mile­stones and royalties on ex-U.S. sales

Cambridge, MA and Summit, NJ (Press Release) – bluebird bio, Inc. (Nasdaq: BLUE) and Celgene Corpo­ra­tion (Nasdaq: CELG) to­day an­nounced that the com­pa­nies have entered into an agree­ment to co-develop and co-promote bb2121, an inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy for the poten­tial treat­ment of patients with re­lapsed/refractory mul­ti­ple myeloma in the United States.

“Entering into this co-development and co-promotion part­ner­ship with Celgene is a sig­nif­i­cant step for­ward in build­ing a fully integrated on­col­ogy fran­chise for bluebird and to­geth­er, …