Invitae, a medical genetics company, announced the availability of a testing program, Detect Hereditary Pancreatic Cancer, that offers no-charge genetic testing and counseling to patients with pancreatic cancer.
Adaptimmune Therapeutics plc said FDA has granted Orphan Drug Designation to SPEAR T-cells targeting MAGE-A4 (Adaptimmune's ADP-A2M4 program) for the treatment of soft tissue sarcomas.
BioXcel Therapeutics Inc. said FDA has granted Orphan Drug Designation for BXCL701, an investigational orally-available systemic innate immunity activator with dual mechanisms of action, for the treatment of acute myeloid leukemia.
FDA has granted an accelerated approval to Rozlytrek (entrectinib) for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.
Syapse and the FDA Oncology Center of Excellence signed a multi-year Research Collaboration Agreement focused on the use of real-world evidence to support regulatory decision-making.
FDA has granted Breakthrough Therapy Designation for Calquence (acalabrutinib) as a monotherapy for adult patients with chronic lymphocytic leukemia.
The European Commission has approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.
The European Commission has approved variations to broaden the use of Imbruvica (ibrutinib) in two indications.
FDA has accepted for review the filing of a supplemental New Drug Application for XTANDI (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer.
The Japan Ministry of Health, Labor and Welfare approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
