The FDA has granted a priority review designation to a supplemental biologics license application for niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior chemotherapy regimens, and who have either a BRCA mutation or have homologous recombination deficiency and progressed >6 months after their last platinum-based chemotherapy.
Howard S. Hochster, MD, provides insight into TAS-102 (trifluridine/tipiracil; Lonsurf) and highlights other important research being conducted in the colorectal cancer space.
Evan Y. Yu, MD, discusses updated data from cohort A of the KEYNOTE-365 trial in patients with metastatic castration-resistant prostate cancer.
Ana Acuna-Villaorduna, MD, provides further insight into the study that compares age and race as factors for the incidence of early-onset colorectal cancer.
Nivolumab (Opdivo) did not achieve statistical significance for improved overall survival compared with sorafenib (Nexavar) as a frontline therapy for patients with unresectable hepatocellular carcinoma as per a prespecified analysis, missing the primary endpoint of the phase III CheckMate-459 trial.
Jared Weiss, MD, discusses key trials in nonsquamous non–small cell lung cancer in depth and their impact on the field.
The European Commission has approved single-agent talazoparib for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer.
The combination of atezolizumab (Tecentriq) and cobimetinib (Cotellic) did not improve progression-free survival compared with pembrolizumab (Keytruda) in patients with previously untreated BRAF V600 wild-type melanoma, missing the primary endpoint of the phase III IMspire170 trial.
The FDA has issued a complete response letter to Daiichi Sankyo informing the company that its new drug application would not be approved for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia.
Ezzat Elhassadi, MD, highlights research being done to address the unmet need of patients with p53-mutant mantle cell lymphoma and the challenges faced in the current treatment paradigm.
Ruth O'Regan, MD, discusses current approaches to treatment escalation and de-escalation, as well as the use of retrospective molecular profiling, which may help address some unanswered questions in the field.
Allen L. Cohn, MD, discusses how the increased incidence of pancreatic cancer has spurred an abundance of novel treatment approaches to combat the disease.
Nirav S. Dhruva, MD, highlightes key advances made in non–small cell lung cancer, the importance of PD-L1 expression testing, and ongoing efforts to bridge the gap between community and academic centers in lung cancer care.
Anthony B. El-Khoueiry, MD, provides insight on the rapidly evolving treatment options in hepatocellular carcinoma.
Japan’s Pharmaceuticals and Medical Devices Agency approved olaparib as a maintenance treatment for patients with BRCA-mutant ovarian cancer after undergoing first-line chemotherapy.
Reem Karmali, MD, MS, shares early data with ibrutinib maintenance therapy and highlights recent advances and challenges in the treatment of patients with mantle cell lymphoma.
Scott J. Antonia, MD, PhD, discusses the pivotal data that renewed interest in stage III unresectable non–small cell lung cancer and anticipated data that are expected to advance the field even further.
The Ministry of Health, Labor and Welfare of Japan has approved quizartinib for the treatment of adult patients with relapsed/refractory FTL3-ITD–positive acute myeloid leukemia, as detected by an MHLW-approved assay.
Combining telaglenastat (CB-839) with everolimus (Afinitor) doubled the median progression-free survival versus everolimus alone in heavily pretreated patients with advanced renal cell carcinoma.
Entrectinib received its first regulatory approval, as Japan’s Ministry of Health, Labour and Welfare has approved the drug for the treatment of adult and pediatric patients with NTRK fusion–positive, advanced recurrent solid tumors.
The European Commission has approved olaparib as a single agent for the maintenance treatment of adult patients with advanced BRCA1/2-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.
The FDA has granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.
Pfizer Inc. has entered into a definitive merger agreement with Array BioPharma, in which Pfizer will acquire Array BioPharma for $48 per share in cash, leading to a total enterprise value of an estimated $11.4 billion.
Chemotherapy-free treatment with single-agent acalabrutinib provided a statistically significant and clinically meaningful improvement in progression-free survival compared with physicians’ choice of standard therapy in patients with previously treated chronic lymphocytic leukemia.
Sujatha Nallapareddy, MD, discusses how personalized therapy has improved the outlook for patients with colorectal cancer and sheds light on some of the challenges that lie ahead.
Chad Pecot, MD, discusses practice-changing immunotherapy research that has read out in squamous non–small cell lung cancer, emerging biomarkers under investigation, and logical combinations that beg for further exploration.
Jeffrey M. Clarke, MD, discusses the optimal targeted therapies for the frontline treatment of patients with EGFR-positive NSCLC and sequencing beyond progression.
The FDA has approved ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.
Neal E. Ready, MD, PhD, highlights recent advances that have been made in the treatment of small cell lung cancer, the promise of immunotherapy, and opportunities to improve patient care.
Christopher Lieu, MD, highlights updates on biomarker-directed therapy with colorectal cancer and ongoing research being done with immunotherapy.
