FDA Grants Priority Review to Sarclisa for Multiple Myeloma

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Sarclisa was granted a priority review by the Food and Drug Administration for patients newly diagnosed with multiple myeloma who are ineligible for blood transplants.

Sarclisa was granted a priority review by the FDA for certain patients with multiple myeloma.

The Food and Drug Administration (FDA) has accepted Sarclisa (isatuximab) for priority review for patients who have recently received a diagnosis of multiple myeloma and are blood transplant-ineligible.

The FDA has decided to grant a priority review to Sarclisa after promising findings from the phase 3 IMROZ study, according to a press release from Sanofi, the manufacturer of Sarclisa. A priority review aims to take action on a drug within six months versus 10 months for a standard review. A priority review is typically granted by the FDA to a drug when it shows significant benefits regarding safety and effectiveness, according to the agency.

In the phase 3 study, Sarclisa has been evaluated in combination with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone.

About the Phase 3 IMROZ Study

The phase 3 study included 475 patients newly diagnosed with multiple myeloma and are ineligible for blood transplants, according to the trial listing on ClinicalTrials.gov.

The main objective is to determine the benefit of adding Sarclisa to Velcade, Revlimid and dexamethasone regarding progression-free survival (PFS; time without the disease worsening or spreading). Researchers compared the treatment regimen to Velcade, Revlimid and dexamethasone without Sarclisa, the listing noted.

According to the news release, the phase 3 study had reached its main objective in December 2023. Researchers determined that the PFS was significantly improved in patients who received the Sarclisa regimen versus the regimen without Sarclisa.

More data on the IMROZ study will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting during an oral presentation.

About Sarclisa in Patients With Multiple Myeloma

The targeted date for the potential approval of Sarclisa for patients newly diagnosed with multiple myeloma who are ineligible for transplants is Sept. 27, 2024, according to the release. Of note, if approved, Sarclisa could mark the first anti-CD38 treatment with the standard-of-care regimen.

An anti-CD38 treatment is a type of monoclonal antibody that binds onto CD38 proteins and helps the immune system destroy cancer cells, as the National Cancer Institute defines.

In March 2020, Sarclisa was first approved in combination with Pomalyst (pomalidomide) and dexamethasone for patients with multiple myeloma who received at least two previous lines of therapy.

Sarclisa was approved again in March 2021 along with standard of care — consisting of Kyprolis (carfilzomib) and dexamethasone — for patients with relapsed or refractory multiple myeloma who received one to three previous lines of treatment.

“Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease,” said Dr. Dietmar Berger, chief medical officer and global head of development at Sanofi, in the news release. “The filing acceptances, as well as the FDA’s priority review designation, reinforce our confidence in Sarclisa as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer.”

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