Sanofi SNY announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab).

With this nod, Sarclisa is now approved, in combination with Velcade (bortezomib) and Bristol Myers’ BMY Revlimid (lenalidomide) and dexamethasone (“VRd”), for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant.

This approval was expected as the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending the approval of the Sarclisa-VRd combo in the above indication in November.

The EC and CHMP decisions are based on data from the phase III IMROZ study, which evaluated Sarclisa plus standard-of-care (SOC) VRd in NDMM patients who are not eligible for transplant. The study met its primary endpoint — treatment with the Sarclisa-VRd combination reduced the risk of disease progression or death by 40% compared to VRd in the given patient population.

Following this approval, Sarclisa became the first anti-CD38 therapy, in combination with VRd, for treating transplant-ineligible NDMM patients. The Sarclisa combination therapy was approved for a similar indication by the FDA in September, also supported by data from the IMROZ study.

SNY Stock Performance

Sanofi’s shares have gained over 3% in the past year against the industry’s 4% decline.

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Sanofi’s Progress With Sarclisa in the MM Space

This latest EC nod marks the first approval for Sarclisain NDMM patients and the third overall approval for the drug in the region.

Sarclisa, in combination with Bristol Myers’ Pomalyst (pomalidomide) and dexamethasone, is approved for treating adult patients with MM who have received at least two prior therapies, including Revlimid and a proteasome inhibitor. The SNY drug is also approved in combination with Amgen’s AMGN Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed/refractory MM (RRMM) who have received 1–3 prior lines of therapy. The drug is also approved for similar indications in the United States.

Both Bristol Myers’ Pomalyst and Revlimid have been approved for the MM space. Amgen’s Kyprolis is also approved in combination with other drugs to treat certain RRMM patients.

Sanofi is also evaluating Sarclisa in multiple ongoing phase II and phase III studies in combination with other current SOC therapies to treat MM across different settings. The company is also prioritizing patient comfort by evaluating a subcutaneous (SC) formulation of the drug. Earlier this month, management reported data from a late-stage study that showed that the SC formulation of Sarclisa was just as effective as the intravenous formulation of the drug in RRMM indication. The SC version is also being evaluated in various other studies across different combinations and lines of therapy.

The drug's expanded use in NDMM patients is expected to boost sales in the upcoming quarters. Successful development in other MM indications would also help the company compete with J&J JNJ, whose blockbuster anti-CD38 therapy Darzalex is approved for similar use in the MM space. The J&J drug is currently approved in MM indications across different settings for use either as monotherapy or in combination with other drugs.

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Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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