Roche Reports Acceptance of BLA for Fixed-Dose SC Combination of Perjeta and Herceptin to Treat HER2-Positive Breast Cancer

 Roche Reports Acceptance of BLA for Fixed-Dose SC Combination of Perjeta and Herceptin to Treat HER2-Positive Breast Cancer

Roche Reports Acceptance of BLA for Fixed-Dose SC Combination of Perjeta and Herceptin to Treat HER2-Positive Breast Cancer

Shots:

  • The BLA is based on P-III FeDeriCa study assessing FDC of Perjeta + Herceptin (SC) + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive eBC who are being treated in the neoadjuvant & adjuvant settings
  • The P-III FeDeriCa study resulted in meeting its 1EPs & 2EPs i.e. non-inferior levels of Perjeta & Herceptin in the blood during a given dosing interval (Ctrough) respectively, demonstrated comparable total pCR, no new signals were identified including no differences in cardiac toxicity
  • The FDC combination is a new SC formulation that combines Perjeta and Herceptin with Halozyme’s Enhanze drug delivery technology which is based on (rHuPH20) with its expected FDA’s approval by Oct 18, 2020

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pantone Canvas Gallery

Tuba Khan

Tuba Khan is an Editor and Digital Marketing expert at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in Lifesciences industry. She covers Pharma, Medical devices, Diagnostics and Digital health segment. Tuba also has an experience of digital and social media marketing and can run the campaign independently. She is also certified as a Digital marketer and social media marketer. She can be contacted on tuba@pharmashots.com

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