Category: news

FDA accepts AstraZeneca’s drug for multiple B-cell and other cancers.
August 2, 2017 Off

FDA accepts AstraZeneca’s drug for multiple B-cell and other cancers.

By Dino Mustafić

The US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma. This potential new medicine is in development for the treatment of multiple B-cell and other cancers.

Celgene, Agios get FDA’s approval for AML treatment IDHIFA
August 1, 2017 Off

Celgene, Agios get FDA’s approval for AML treatment IDHIFA

By Dino Mustafić

Celgene Corporation  and Agios Pharmaceuticals, Inc. today announced that IDHIFA  was granted approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory AML (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA approved test.

AstraZeneca’s MCL drug won FDA’s breakthrough therapy designation
August 1, 2017 Off

AstraZeneca’s MCL drug won FDA’s breakthrough therapy designation

By Dino Mustafić

AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

August 1, 2017 Off

Transgene testing Opdivo with Pexa-Vec to treat HCC – first patient treated

By Dino Mustafić

Transgene has treated the first patient in a Phase 1/2 clinical trial for the combination of Pexa-Vec with Opdivo as a first-line treatment of advanced hepatocellular carcinoma (HCC). The trial will assess the safety and tolerability as well as the anti-tumor activity and efficacy of this immunotherapy combination regimen in up to 36 patients (NCT03071094).  This tumour accounts for approximately 75% of liver cancers.