Sanofi snags FDA thumbs up for Sarclisa as 1st cancer drug delivered by on-body injector
The FDA has granted approval for Sanofi’s Sarclisa, marking the first time a cancer medication is delivered via a wearable on-body injector.
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The brief
Food and Drug Administration has approved the subcutaneous injection form of isatuximab-irfc for the treatment of multiple myeloma. This authorization introduces a new administration method for the medication, which utilizes a wearable on-body device. Coverage from Reuters, Fierce Pharma, PharmTech.com, Yahoo Finance, and TradingView emphasizes the regulatory milestone of the device.
Reports highlight that this is the first cancer drug to be approved for delivery through this type of injector technology. Simultaneously, Yahoo Finance notes that Sanofi is facing a separate antitrust probe initiated by the EU. Future developments remain dependent on the integration of the injector into clinical practice.
Coverage does not yet specify how the EU antitrust investigation might impact the company's broader operations or the rollout of the newly approved therapy.
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Quick answers
What is the primary innovation of the approved Sarclisa delivery?
It is the first cancer drug approved for administration through a wearable on-body injector.
What condition is this medication approved to treat?
The subcutaneous injection is approved for multiple myeloma indications.
Are there other regulatory issues facing Sanofi?
Yes, coverage indicates that the EU has opened an antitrust probe into the company.
Coverage (5)
- Sanofi (ENXTPA:SAN) Wins FDA Nod For Sarclisa Escena As EU Opens Antitrust Probe Yahoo Finance · 19h ago
- FDA Approves Isatuximab-Irfc For Subcutaneous Injection For Multiple Myeloma Indications On July 9 TradingView · 19h ago
- The Implications of Isatuximab-irfc’s FDA Approval for Multiple Myeloma PharmTech.com · 19h ago
- US FDA approves Sanofi's wearable injector form of blood cancer drug Reuters · 19h ago
- Sanofi snags FDA thumbs up for Sarclisa as 1st cancer drug delivered by on-body injector Fierce Pharma · 19h ago
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