Braftovi
Oncology· 754 cited findings· 1 source document
Company: Pfizer Inc. →
What the regulatory reviews say
Braftovi (encorafenib) received regulatory approval on June 27, 2018, April 8, 2020, and October 11, 2023, under application number 210496/017 as a Priority sNDA. The median age of patients in efficacy trials was 61 years, with female participants comprising 51.0% and 49.6% of study populations. Key trials included BREAKWATER (NCT04607421) and BEACON CRC (NCT02928224).
In efficacy analyses, the Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) was 60.9% and 40.0%, with a median Duration of Response (DOR) of 13.9 months and 11.1 months, respectively. The Complete Response (CR) rate by BICR was 2.7%. The Odds Ratio for ORR was 2.443 with a 1-sided p-value of 0.0008. The number of patients in the primary ORR analysis was 110. Discontinuation due to progressive disease was observed at rates of 61.4%, 20.8%, and 31.7%.
Safety findings indicate discontinuation due to adverse events at 5.7%, 4.7%, and 9.1%. Discontinuation due to death occurred at rates of 3.4%, 1.3%, and 4.1%. Withdrawal by subject was reported at 5.1%, 5.5%, and 11.5%, while discontinuation due to global deterioration of health status was 3.2%.
Key figures — cited to the source page
| Approval date | 27 June 2018 | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.38 |
| Objective Response Rate (ORR) by BICR | 60.9 | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.75 |
| median DOR | 13.9 | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.17 |
| Complete Response (CR) rate by BICR | 2.7 | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.75 |
| discontinuation due to adverse event | 9.1 | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.68 |
| discontinuation due to death | 4.1 | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.68 |
| Application Type | sNDA | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.1 |
| Priority | Priority | ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2, p.1 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.