Genmab said its licensing partner, Janssen Biotech, Inc. has submitted the first part of a regulatory submission to FDA for a label expansion to include the use of daratumumab in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant.
FDA approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
The EC has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma. This decision represents the first approval of an immuno-oncology combination therapy for patients with this type of cancer in the E.U.
QIAGEN announced the Japanese Pharmaceuticals and Medical Device Agency has approved the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer's Vizimpro (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer. The therascreen EGFR RGQ PCR Kit is registered in more than 40 countries globally. This marks the first companion diagnostic approval for QIAGEN in Japan.
Genentech announced FDA has accepted the company's supplemental Biologics License Application for Tecentriq (atezolizumab) in combination with Abraxane (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer who do not have EGFR or ALK genomic tumor aberrations.
FDA Commissioner Scott Gottlieb has taken to Twitter to say that due to the partial shutdown, the FDA cannot accept new 2019 user fees.
FDA Commissioner Scott Gottlieb has taken to Twitter again to state the FDA “continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we'll take action if we determine a company is deliberately misleading the public about the safety of these important products.”
AstraZeneca and Merck said FDA has approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
FDA has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy.
Merck said FDA has approved Keytruda for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, based on the results of the Cancer Immunotherapy Trials Network's CITN-09/KEYNOTE-017 trial.
