Eli Lilly and Company and Merck extended an existing collaboration to evaluate the safety and efficacy of the combination of Lilly’s Alimta (pemetrexed for injection) and Merck’s Keytruda (pembrolizumab) in a phase III study in first-line nonsquamous non-small cell lung cancer. The study will be sponsored by Merck and will be open to patients with... […]
FDA approved Ninlaro (ixazomib), developed by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor. The approval was based on an improvement... […]
FDA granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.
FDA approved Cotellic tablets (cobimetinib) for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. Cobimetinib is not indicated for treatment of patients with wild-type BRAF melanoma.
FDA granted accelerated approval to Tagrisso (osimertinib) tablets for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.
MD Anderson Cancer Center entered into a collaboration with CytomX Therapeutics to research Probody-enabled chimeric antigen receptor natural killer cell therapies, to be known as ProCAR-NK cell therapies. MD Anderson will develop allogeneic umbilical cord blood and peripheral blood derived NK-cell therapies and combine it with CytomX’s Probody technology to address new targets for this […]
FDA granted Breakthrough Therapy Designation to pexidartinib (formerly PLX3397) for the treatment of tenosynovial giant cell tumor where surgical removal of the tumor would be associated with potentially worsening functional limitation or severe morbidity. Currently, there is no FDA-approved systemic therapy for the treatment of TGCT. The designation was granted based on results from an […]
Researchers from The Cancer Genome Atlas Network recently published two studies—one identifying seven distinct molecular subtypes of prostate cancer, and one exploring the genetic drivers of papillary renal cell carcinoma.
FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.
FDA granted Priority Review for defibrotide for the treatment of patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with evidence of multi-organ dysfunction following hematopoietic stem-cell transplantation. FDA review of the new drug application is expected to be completed by March 31, 2016. The application, submitted by Jazz Pharmaceuticals plc, includes safety... […]
