President Donald Trump signed $1.4 trillion in spending bills Dec. 20 that includes a $212.5 million increase for NCI to cope with an avalanche of grant applications and improve the institute's declining success rates.
Thomas Sellers, director of Moffitt Cancer Center, and Alan List, president and CEO of the center, stepped down Dec. 18 after an internal review revealed that they violated “conflict of interest rules through their work in China,” cancer center officials said.
The FDA Oncologic Drugs Advisory Committee in a session Dec. 17 and 18 considered three applications that were arranged thematically, to show how the agency is approaching indications where the number of patients is small and the disease catastrophic.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.
FDA has approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
FDA approved Foundation Medicine's FoundationOne CDx to be used as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
FDA has granted priority review for a new supplemental Biologics License Application for Keytruda, which seeks approval of the anti-PD-1 therapy as monotherapy in patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
FDA accepted a new drug application for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements for Priority Review.
The National Medical Products Administration in China approved Merck's anti-PD-1 Keytruda in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer.
China's National Medical Products Administration granted AstraZeneca and Merck marketing authorization for Lynparza (olaparib) as a first-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. The companies received marketing authorization Dec. 5.
