FDA’s Oncology Center of Excellence launched the “Send Your Oncology Research Questions to FDA” crowdsourcing challenge. OCE is using this challenge to provide an opportunity for interested stakeholders to submit ideas for research using pooled analyses of oncologic clinical trial data directly to FDA’s scientific staff.
FDA has granted accelerated approval to Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.
FDA has accepted the company’s supplemental New Drug Application for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma.
FDA has accepted the supplemental Biologics License Application for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial.
The European Commission has approved an additional indication for the oral once-daily therapy Xtandi (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma.
Zynlonta (loncastuximab tesirine-lpyl), a CD19-directed antibody and alkylating agent conjugate, was granted FDA Accelerated Approval for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.
The Ventana MMR RxDx Panel has received FDA approval for advanced or recurrent endometrial cancer patients.
Mobocertinib (TAK-788) has received FDA Priority Review for the treatment of adult patients with epidermal growth factor receptor Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer, as detected by an FDA-approved test, who have received prior platinum-based chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Onureg (azacitidine tablets; CC-486) as a maintenance therapy in adult patients with acute myeloid leukemia.
