FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.”
FDA approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab), including treatment of moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn's Disease in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
FDA granted Breakthrough Therapy Designation for the Janssen Pharmaceutical Companies of Johnson & Johnson's JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen-directed chimeric antigen receptor T-cell therapy in previously treated patients with multiple myeloma.
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.
FDA takes second action under international collaboration, approving treatment option for CLL or SLL
As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.
