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FDA approves Sanofi’s key cancer drug Sarclisa for myeloma

First cancer drug wholly owned by company to be approved in past decade


The US Food and Drug Administration (FDA) has approved Sanofi’s cancer treatment Sarclisa for multiple myeloma, bolstering the company’s ambitions in the therapy area.

New CEO Paul Hudson’s plans to revamp Sanofi’s business are now in full swing, with the approval of Sarclisa (isatuximab-irfc) marking the first time a drug wholly owned by the company has been granted a green light by the agency for the past decade.

The drug is designed to target the CD38 protein found on the surface of myeloma cells, inducing programmed tumour cell death – also known as apoptosis.

It is the second treatment to target the CD38 protein after Johnson and Johnson’s Darzalex (daratumumab), which is already available across a range of multiple myeloma indications.

Sarclisa will now be available for patients with relapsed or refractor multiple myeloma who have received at least two prior therapies, including Celgene’s Revlimid (lenalidomide) and a proteasome inhibitor.

It has been approved for use in combination with pomalidomide and dexamethasone (pom-dex), a standard regimen for the treatment of myeloma.

A host of new treatments for myeloma have entered the market over the last decade, but despite these advancements patients often relapse or become resistant to certain therapies.

That makes the later line drugs, such as Sarclisa, important for those patient who have exhausted other options.

The approval of Sarclisa in this setting is based on the phase 3 ICARIA-MM study – when added to pom-dex, the drug demonstrated a statistically significant improvement in progression-free survival, with a median PFS rate of 11.53 months compared to 6.47 months with pom-dex alone.

“Most patients with multiple myeloma unfortunately relapse and become refractory to currently available therapies,” said Paul Richardson, principal investigator of the ICARIA-MM study and clinical programme leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.

“Sarclisa used in combination with pomalidomide and dexamethasone offers an important new treatment option for patients in the US living with this incurable disease,” he added.

Importantly, the approval of Sarclisa aligns with Sanofi’s narrower focus – last year, Hudson revealed a new strategy for the company, shedding research in its troubled diabetes and cardiovascular franchises to focus more on other key growth areas.

That included its blockbuster immunology treatment Dupixent (dupilumab), its vaccine business and a robust pipeline littered with potential candidates for rare disease, multiple sclerosis and breast and lung cancer.

According to the company’s strategy statement, additional core drivers include treatments for oncology, haematology, rare diseases and neurology.

Article by
Lucy Parsons

3rd March 2020

From: Regulatory



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