Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

 Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

Shots:

  • The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required
  • The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence indicating that the medicine may provide a substantial improvement over available therapy on at least one clinically significant endpoint
  • MK-6482 (formerly PT2977) is an investigational oral HIF-2α inhibitor, currently being evaluated in a P-III  trial in advanced RCC (NCT04195750), a P-II trial in VHL-associated RCC (NCT03401788), and a P-I/II dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738)

Click here ­to­ read full press release/ article | Ref: Merck | Image: Market Watch

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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