The FDA awarded Array Biopharma's mutant metastatic colorectal cancer treatment the breakthrough therapy designation.
Here's what you should know:
1. Array's encorafenib, binimetinib and cetuximab combination therapy has the potential to be the first approved treatment for patients with BRAFV600E-mutant metastatic CRC. The therapy is used after previous unsuccessful treatments.
2. The FDA will begin an expedited review process of the therapy. The FDA only awards the breakthrough designation when the treatment demonstrates a substantial improvement over existing therapies.
3. Array presented phase 3 clinical trial data on the therapy at ESMO 20th World Congress on Gastrointestinal Cancer, June 20 to June 23 in Barcelona, Spain.
4. The phase 3 data were fully mature through 12.6 months and showed:
- One-year survival rate was 62 percent
- Median progression-free survival was eight months and was similar between patients previously receiving one line of therapy or two lines of therapy
- Confirmed overall response rate was 48 percent. Among patients receiving only one prior treatment, overall response rate was 62 percent.
- The triplet combination was well-tolerated with no unexpected toxicities.
- The most common adverse events were fatigue, anemia, increased blood creatine kinase and increased aspartate aminotransferase
Array CMO Victor Sandor, MD, said, "We are delighted that the FDA has recognized the potential of this combination for patients with BRAFV600E-mutant metastatic colorectal cancer. As there are no regimens approved specifically for BRAFV600E-mutant mCRC, this designation provides us with the opportunity to work closely with the FDA to potentially accelerate our effort to bring an important treatment option to these patients in critical need."