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Sanofi (SNY) Gets FDA Approval for Sarclisa Label Expansion
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Sanofi (SNY - Free Report) announced that the FDA has granted approval to the label expansion of Sarclisa (isatuximab-irfc) for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) in the second- to fourth-line setting. The drug received the nod in combination with Amgen’s (AMGN - Free Report) Kyprolis (carfilzomib) and dexamethasone (Kd) for treating adults with RRMM who have received one to three prior lines of therapy.
The approval was based on encouraging data from the phase III IKEMA study evaluating the combination regime in relapsed multiple myeloma patients.
Last year, Sarclisa received its first FDA approval in combination with Bristol-Myers’ (BMY - Free Report) Pomalyst (pomalidomide) and dexamethasone for treating adults with RRMM having received at least two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor.
Data from the IKEMA study showed that Sarclisa in combination with Kd reduced the risk of disease progression or death by 45% compared to Kd alone, which is the current standard-of-care for patients with multiple myeloma. Moreover, 39.7% of patients achieved complete response.
Sanofi stock has gained 1.8% this year so far against a decrease of 0.1% for the industry.
Launch of Sarclisa and Libtayo, a promising skin cancer drug, boosted sales of the company’s Oncology segment in 2020. Last month Libtayo also received a label expansion from the FDA. Label expansion of these two drugs is likely to bring additional oncology revenues in 2021.
Meanwhile, the company is developing a COVID-19 vaccine in partnership with Translate Bio (TBIO - Free Report) . Earlier this month, the companies initiated a phase I/II study to evaluate their mRNA-based vaccine candidate, MRT5500. Sanofi is also making an adjuvanted recombinant protein-based COVID-19 vaccine candidate in partnership with Glaxo. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology.
Sanofi has entered into an agreement with Germany’s BioNTech to support the manufacture and supply of the latter’s COVID-19 vaccine candidate, which is being co-developed with Pfizer.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
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Sanofi (SNY) Gets FDA Approval for Sarclisa Label Expansion
Sanofi (SNY - Free Report) announced that the FDA has granted approval to the label expansion of Sarclisa (isatuximab-irfc) for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) in the second- to fourth-line setting. The drug received the nod in combination with Amgen’s (AMGN - Free Report) Kyprolis (carfilzomib) and dexamethasone (Kd) for treating adults with RRMM who have received one to three prior lines of therapy.
The approval was based on encouraging data from the phase III IKEMA study evaluating the combination regime in relapsed multiple myeloma patients.
Last year, Sarclisa received its first FDA approval in combination with Bristol-Myers’ (BMY - Free Report) Pomalyst (pomalidomide) and dexamethasone for treating adults with RRMM having received at least two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor.
Data from the IKEMA study showed that Sarclisa in combination with Kd reduced the risk of disease progression or death by 45% compared to Kd alone, which is the current standard-of-care for patients with multiple myeloma. Moreover, 39.7% of patients achieved complete response.
Sanofi stock has gained 1.8% this year so far against a decrease of 0.1% for the industry.
Launch of Sarclisa and Libtayo, a promising skin cancer drug, boosted sales of the company’s Oncology segment in 2020. Last month Libtayo also received a label expansion from the FDA. Label expansion of these two drugs is likely to bring additional oncology revenues in 2021.
Meanwhile, the company is developing a COVID-19 vaccine in partnership with Translate Bio (TBIO - Free Report) . Earlier this month, the companies initiated a phase I/II study to evaluate their mRNA-based vaccine candidate, MRT5500. Sanofi is also making an adjuvanted recombinant protein-based COVID-19 vaccine candidate in partnership with Glaxo. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology.
Sanofi has entered into an agreement with Germany’s BioNTech to support the manufacture and supply of the latter’s COVID-19 vaccine candidate, which is being co-developed with Pfizer.
Sanofi Price
Sanofi price | Sanofi Quote
Zacks Rank
Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>