FDA News

FDA approves once-weekly Kyprolis for relapsed, refractory multiple myeloma

Photo of David Siegel
David S. Siegel

The FDA expanded approval of carfilzomib to include a once-weekly dose in combination with dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma.

Carfilzomib (Kyprolis, Amgen), a selective proteasome inhibitor, had been approved for twice-weekly use, administered at 27 mg/m2. The expanded approval was based on data from the open-label phase 3 ARROW trial.

As HemOnc Today previously reported, researchers presented results from the trial at ASCO Annual Meeting in June.

The analysis included 478 patients aged 18 years or older with relapsed/refractory multiple myeloma, all of whom underwent two or three prior treatments, including with a proteasome inhibitor and immunomodulatory agent.

Researchers randomly assigned patients 1:1 to once-weekly 70 mg/m2 carfilzomib with dexamethasone or twice-weekly 27 mg/m2 carfilzomib with dexamethasone.

Patients assigned once-weekly carfilzomib achieved significantly longer median PFS (11.2 months vs. 7.6 months; HR = 0.69; 95% CI, 0.54-0.88). Researchers also reported a higher overall response rate (62.9% vs. 40.8%; P < .0001) and rate of complete response or better (7.1% vs. 1.7%) in the once-weekly group.

“While great progress has been made in the last decade, multiple myeloma remains an incurable disease characterized by a recurring pattern of remission and relapse, and it is important that patients have treatment options that meet their individual needs,” David S. Siegel, MD, PhD, chief of the division of multiple myeloma at John Theurer Cancer Center at Hackensack University Medical Center, said in a company-issued press release. “The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety, and longer duration of therapy versus the twice-weekly regimen studied in the trial, could allow patients to spend more time outside of the infusion center.”

Researchers observed comparable safety profiles between the once-weekly and twice-weekly treatment arms.

The most common treatment-emergent adverse event that occurred among 20% or more of patients included anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.

“In the fight against multiple myeloma, we are committed to continued evidence generation and innovation to serve patients. Kyprolis now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regimen that provides better outcomes with a comparable safety profile,” David M. Reese, MD, executive vice president of research and development at Amgen, said in the release. “We're pleased that the FDA has recognized the importance of bringing more treatment options to cancer patients more quickly through its pilot programs and proud to participate with this Kyprolis data.”

The FDA reviewed this application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to make the development and review of cancer drugs more efficient.

 

 

Photo of David Siegel
David S. Siegel

The FDA expanded approval of carfilzomib to include a once-weekly dose in combination with dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma.

Carfilzomib (Kyprolis, Amgen), a selective proteasome inhibitor, had been approved for twice-weekly use, administered at 27 mg/m2. The expanded approval was based on data from the open-label phase 3 ARROW trial.

As HemOnc Today previously reported, researchers presented results from the trial at ASCO Annual Meeting in June.

The analysis included 478 patients aged 18 years or older with relapsed/refractory multiple myeloma, all of whom underwent two or three prior treatments, including with a proteasome inhibitor and immunomodulatory agent.

Researchers randomly assigned patients 1:1 to once-weekly 70 mg/m2 carfilzomib with dexamethasone or twice-weekly 27 mg/m2 carfilzomib with dexamethasone.

Patients assigned once-weekly carfilzomib achieved significantly longer median PFS (11.2 months vs. 7.6 months; HR = 0.69; 95% CI, 0.54-0.88). Researchers also reported a higher overall response rate (62.9% vs. 40.8%; P < .0001) and rate of complete response or better (7.1% vs. 1.7%) in the once-weekly group.

“While great progress has been made in the last decade, multiple myeloma remains an incurable disease characterized by a recurring pattern of remission and relapse, and it is important that patients have treatment options that meet their individual needs,” David S. Siegel, MD, PhD, chief of the division of multiple myeloma at John Theurer Cancer Center at Hackensack University Medical Center, said in a company-issued press release. “The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety, and longer duration of therapy versus the twice-weekly regimen studied in the trial, could allow patients to spend more time outside of the infusion center.”

Researchers observed comparable safety profiles between the once-weekly and twice-weekly treatment arms.

The most common treatment-emergent adverse event that occurred among 20% or more of patients included anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.

“In the fight against multiple myeloma, we are committed to continued evidence generation and innovation to serve patients. Kyprolis now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regimen that provides better outcomes with a comparable safety profile,” David M. Reese, MD, executive vice president of research and development at Amgen, said in the release. “We're pleased that the FDA has recognized the importance of bringing more treatment options to cancer patients more quickly through its pilot programs and proud to participate with this Kyprolis data.”

The FDA reviewed this application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to make the development and review of cancer drugs more efficient.