Maria (Masha) Babak: FDA grants accelerated approval to Braftovi for the treatment of metastatic colorectal cancer
Maria (Masha) Babak, Head of The Babak Lab and an Assistant Professor at the City University of Hong Kong, shared a post by The Babak Lab on LinkedIn, adding:
“Excited to see the FDA grant accelerated approval to Braftovi for the treatment of metastatic colorectal cancer!
This approval represents a significant step forward in the fight against colorectal cancer and offers new hope for patients who previously had limited treatment options.
This milestone is a testament to the power of collaborative research.”
The Babak Lab shared a post on LinkedIn:
“Clinical Monday Exciting news in the fight against metastatic colorectal cancer (mCRC)!
The FDA has granted accelerated approval to Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 for patients with BRAF V600E mutation-positive mCRC. This marks a significant advancement in treatment options for this patient population.
Key highlights from the BREAKWATER trial (NCT04607421):
- Improved Objective Response Rate (ORR): 61% in the Braftovi + cetuximab + mFOLFOX6 arm compared to 40% in the control arm.
- Promising Duration of Response (DoR): Median DoR of 13.9 months in the Braftovi combination arm, compared to 11.1 in the control arm.
This accelerated approval is based on compelling efficacy data and is a testament to the collaborative efforts under Project Orbis and Health Canada | Santé Canada. Further evaluation of progression-free survival and overall survival is ongoing.
Learn more about Braftovi and its prescribing information on Drugs atFDA or by clicking the link.”
Dr. Maria (Masha) Babak is the Head of The Babak Lab and an Assistant Professor at the City University of Hong Kong. In November 2020, she joined the City University of Hong Kong as an assistant professor. Dr. Babak received the Graeme Hanson-AsBIC Early Career Award in 2022.Her research interests are at the intersection of chemistry, biology, and medicine, with a focus on the discovery and preclinical development of anticancer drugs for resistant and aggressive cancers with limited treatment options, such as malignant pleural mesothelioma and brain metastases. She received the Yvonne Award by OncoDaily in the “mentorship” category.
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