Specialty Pharma Journal Specialty, Precision & Technology
BOULDER, Colo., June 27, 2018 /PRNewswire/ — Array BioPharma Inc. (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI™ capsules in combination with MEKTOVI® tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma. …
Tag Archives: BRAF
June, 2018
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5 June
Opdivo Demonstrates Sustained, Superior Recurrence-Free Survival Versus Yervoy in Late-Stage Melanoma Trial
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection. In updated results from the study, Opdivo continued to demonstrate statistically longer recurrence-free survival (RFS) of …
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5 June
Array Announces Additional Median Overall Survival Results of Encorafenib and Binimetinib in Patients with Braf-Mutant Advanced Melanoma
BOULDER, Colo., June 4, 2018 /PRNewswire/ — Array BioPharma Inc. (NASDAQ: ARRY) today announced updated results from the Phase 3 COLUMBUS trial in BRAF-mutant advanced melanoma. The results showed median overall survival (mOS) was 33.6 months for patients treated with the combination of encorafenib and binimetinib compared to 16.9 months for patients treated with vemurafenib as …
May, 2018
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7 May
FDA Approves New Uses for Tafinlar and Mekinist for the Treatment of BRAF-Positive Anaplastic Thyroid Cancer
The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive). …
December, 2017
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21 December
FDA Approves Bristol-Myers’ Opdivo as Adjuvant Therapy in Melanoma Patients
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.1 The purpose of adjuvant therapy is to reduce the …
October, 2017
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20 October
Veracyte Presents New Data Validating Accuracy of BRAF V600E and Parathyroid Tissue Classifiers
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (NASDAQ: VCYT) announced that data presented at the 87th Annual Meeting of the American Thyroid Association (ATA) being held October 18-22 in Victoria, BC, Canada demonstrate the accuracy of identification of BRAF V600E and parathyroid tissue through new classifiers developed in conjunction with the next-generation Afirma …
September, 2017
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13 September
FDA to Review Array BioPharma’s NDAs for Binimetinib and Encorafenib for Advanced BRAF-Mutant Melanoma
BOULDER, Colo., Sept. 12, 2017 /PRNewswire/ — Array BioPharma (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Applications (NDAs) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, …
July, 2017
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5 July
Array Submits NDA to FDA for Binimetinib and Encorafenib in Advanced Melanoma
BOULDER, Colo., July 5, 2017 /PRNewswire/ — Array BioPharma (Nasdaq: ARRY) today announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the …