FDA has approved Herzuma (trastuzumab-pkrb) for injection in the same indications as the biosimilar Herceptin.
Ideaya Biosciences Inc. and Pfizer Inc. have formed a clinical trial collaboration and supply agreement.
FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma
FDA granted accelerated approval to the combination of nivolumab and ipilimumab (Opdivo and Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
FDA has accepted Mylan's Biologics License Application or MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway.
FDA has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
Thermo Fisher Scientific and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, signed an agreement to co-develop a companion diagnostic in oncology.
The European Commission has approved Venclyxto in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia, who were previously untreated.
FDA has approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
FDA has granted an investigational CD30-directed autologous chimeric antigen receptor T cell (CD30 CAR-T) therapy Regenerative Medicine Advanced Therapy designation for treatment of patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
FDA has granted Fast Track designation to tipifarnib for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma and nodal peripheral T-cell lymphoma with T follicular helper (TFH) phenotype.
