publication date: Apr. 10, 2020

Drugs & Targets

FDA approves Braftovi + cetuximab for BRAFV600E-mutant metastatic CRC indication

FDA has approved Braftovi (encorafenib) in combination with Erbitux (cetuximab) for the treatment of adult patients with metastatic colorectal cancer with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.

The approval is based on results from the BEACON CRC trial, the only phase III trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.

Braftovi is sponsored by Pfizer.

Based on results from the BEACON CRC trial, Braftovi plus cetuximab showed a median overall survival of 8.4 months (95% CI: 7.5, 11.0) compared with 5.4 months (95% CI: 4.8, 6.6) for Control (irinotecan with cetuximab or FOLFIRI with cetuximab) ([HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]). Additionally, BRAFTOVI plus cetuximab showed an improved objective response rate (ORR) of 20% (95% CI: 13%, 29%) compared with 2% (95% CI: 0%, 7%) for Control (p<0.0001) and median progression-free survival (mPFS) was 4.2 months with BRAFTOVI plus cetuximab (95% CI: 3.7, 5.4) versus 1.5 months with Control (95% CI: 1.4, 1.7) ([HR 0.40, (95% CI: 0.31, 0.52), p<0.0001]).

“BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,”Scott Kopetz, associate professor of gastrointestinal medical oncology at MD Anderson Cancer Center, said in a statement. “As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic CRC who have received prior therapy, BRAFTOVI in combination with cetuximab is a much-needed new treatment option for these patients.”

The most common adverse reactions (AR) (≥ 25%) seen in patients treated with BRAFTOVI in combination with cetuximab were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash. The full prescribing information for BRAFTOVI can be found here.


FDA approves luspatercept-aamt for anemia in adults with MDS

FDA has approved luspatercept-aamt (Reblozyl, sponsored by Celgene Corp) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.

Efficacy was demonstrated in the MEDALIST trial (NCT02631070), a randomized, multi-center, double-blind, placebo-controlled trial in 229 patients with IPSS-R very low, low, or intermediate-risk myelodysplastic syndromes who had ring sideroblasts and required RBC transfusions (2 or more RBC units over 8 weeks). Patients were randomized 2:1 to luspatercept-aamt or placebo. All patients received best supportive care, which included RBC transfusions.

The main efficacy endpoint in MDS-RS and MDS-RS-T was the proportion of patients who were RBC-transfusion independent, defined as the absence of any RBC transfusion during any consecutive 8-week period between Weeks 1 and 24.

Of the 153 patients who received luspatercept-aamt, 58 (37.9%, 95% CI: 30.2, 46.1) were RBC-TI for at least 8 weeks, compared to 10 patients (13.2%, 95% CI: 6.5, 22.9) who received placebo (treatment difference 24.6% (95% CI: 14.5, 34.6; p<0.0001.)


Myriad receives reimbursement for the BRACAnalysis Diagnostic System in Japan

Myriad Genetics has received reimbursement and launched the BRACAnalysis Diagnostic System in Japan to help physicians determine which people affected with breast and ovarian cancer have hereditary breast and ovarian cancer syndrome and qualify for additional diagnostic and medical management.

BRACAnalysis was approved by Japan’s Ministry of Health, Labour and Welfare in November 2019 for this indication.

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