Sanofi SNY announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending the approval of its blood cancer drug, Sarclisa (isatuximab), for expanded use in the multiple myeloma (“MM”) indication.
The CHMP has now recommended approval of Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (“NDMM”) who are eligible for autologous stem cell transplant (“ASCT”).
A final decision from the regulatory body in Europe is expected shortly.
The CHMP's opinion was based on data from the phase III GMMG-HD7, which showed that Sarclisa in combination with VRd induction treatment significantly improved minimal residual disease negativity benefit and prolonged progression-free survival versus VRd alone.
A potential nod would mark the fourth approved indication for Sarclisa in the European Union and the second for first-line use worldwide.
Year to date, shares of Sanofi have lost 0.7% compared with the industry’s decline of 2.6%.
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Current Approved Indications of SNY's Sarclisa
In the first-line setting, Sarclisa in combination with bortezomib, lenalidomide and VRd is already approved in the European Union for treating NDMM in patients who are not eligible for ASCT. The FDA approved Sarclisa for a similar use in the United States in September 2024.
Sarclisa, in combination with Bristol Myers’ BMY Pomalyst (pomalidomide) and dexamethasone, is currently approved to treat adult patients with MM who have received at least two prior therapies, including Revlimid and a proteasome inhibitor. The drug is also approved in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three prior lines of therapy.
Both BMY’s Pomalyst and Revlimid are approved for multiple myeloma.
Sanofi is also evaluating a fixed-dose subcutaneous (“SC”) formulation of Sarclisa for the treatment of R/R MM.
Regulatory filings seeking approval for the Sarclisa SC formulation are expected to be submitted in the United States and Europe shortly.
SNY's Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Exelixis EXEL and Amarin Corporation AMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have increased 21.2%.
EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.
In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.00 to $2.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $1.78. Year to date, shares of AMRN have surged 29.3%.
AMRN’s earnings beat estimates in two of the trailing four quarters, met the same once and missed on the remaining occasion, the average surprise being 29.11%.
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This article originally published on Zacks Investment Research (zacks.com).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
