FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv) Dec. 18 for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death-ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
FDA granted avatrombopag Orphan Drug designation for the potential treatment of chemotherapy-Induced thrombocytopenia.
Karyopharm Therapeutics Inc. has submitted a New Drug Application to FDA, seeking accelerated approval for Xpovio (selinexor), the company's first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with relapsed or refractory diffuse large B-Cell lymphoma after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR-T cell therapy.
Amgen and Allergan plc. submitted a Biologics License Application to FDA for ABP 798, a biosimilar candidate to Rituxan (rituximab).
The China National Medical Products Administration approved the New Drug Application for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase inhibitor as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.”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.
