FDA News

FDA grants breakthrough therapy designation to Darzalex for multiple myeloma

The FDA granted breakthrough therapy designation to daratumumab for its use in combination with standard-of-care regimens for patients with previously treated multiple myeloma.

The designation applies to use of daratumumab (Darzalex, Janssen) — a CD38-directed monoclonal antibody — in combination with the immunomodulatory agent lenalidomide (Revlimid, Celgene) and dexamethasone, or the proteasome inhibitor bortezomib (Velcade; Millennium/Takeda) and dexamethasone.

The FDA previously granted breakthrough therapy designation to daratumumab for the treatment of patients with myeloma who received at least three prior lines of therapy.

“We are pleased that the FDA has granted a second breakthrough therapy designation to daratumumab,” Craig L. Tendler, MD, vice president of late-stage development and global medical affairs for oncology, hematology and supportive care at Janssen, said in a press release. “This is an important recognition of the transformative potential of daratumumab and its possible benefit as a backbone therapy in combination with two of the most widely used regimens for multiple myeloma.”

The FDA based the new breakthrough therapy designation on results of two phase 3 trials.

The CASTOR trial evaluated daratumumab in combination with bortezomib and dexamethasone compared with bortezomib and dexamethasone alone. The POLLUX trial evaluated daratumumab in combination with lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone.

Both trials showed the daratumumab regimens reduced the risk for disease progression or death in previously treated patients.

“We look forward to working closely with the FDA throughout the review process and remain committed to exploring the full clinical benefit of this promising compound for multiple myeloma patients who are eagerly awaiting new treatment options,” Tendler said.

The FDA granted breakthrough therapy designation to daratumumab for its use in combination with standard-of-care regimens for patients with previously treated multiple myeloma.

The designation applies to use of daratumumab (Darzalex, Janssen) — a CD38-directed monoclonal antibody — in combination with the immunomodulatory agent lenalidomide (Revlimid, Celgene) and dexamethasone, or the proteasome inhibitor bortezomib (Velcade; Millennium/Takeda) and dexamethasone.

The FDA previously granted breakthrough therapy designation to daratumumab for the treatment of patients with myeloma who received at least three prior lines of therapy.

“We are pleased that the FDA has granted a second breakthrough therapy designation to daratumumab,” Craig L. Tendler, MD, vice president of late-stage development and global medical affairs for oncology, hematology and supportive care at Janssen, said in a press release. “This is an important recognition of the transformative potential of daratumumab and its possible benefit as a backbone therapy in combination with two of the most widely used regimens for multiple myeloma.”

The FDA based the new breakthrough therapy designation on results of two phase 3 trials.

The CASTOR trial evaluated daratumumab in combination with bortezomib and dexamethasone compared with bortezomib and dexamethasone alone. The POLLUX trial evaluated daratumumab in combination with lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone.

Both trials showed the daratumumab regimens reduced the risk for disease progression or death in previously treated patients.

“We look forward to working closely with the FDA throughout the review process and remain committed to exploring the full clinical benefit of this promising compound for multiple myeloma patients who are eagerly awaiting new treatment options,” Tendler said.