The European Commission approved the use of Rubraca (rucaparib) for a second indication, as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Following recent discussions with FDA, Bristol-Myers Squibb announced the voluntary withdrawal of the sBLA for the Opdivo and low-dose Yervoy (ipilimumab) combination for treatment of first-line advanced non-small cell lung cancer in patients with tumor mutational burden ≥10 mutations/megabase.
FDA issued the final guidance, Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Pathway, that aims to assist sponsors of drug and biological products in developing the Indications and Usage section of product labeling for products approved under the accelerated approval pathway.
FDA has granted Breakthrough Device Designation for Illumina's its pan-cancer assay.
Amgen said the European Commission has approved an expanded indication for Blincyto (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.
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.
