News

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma.

The FDA has accepted a new drug application for tivozanib for the treatment of patients with relapsed/refractory renal cell carcinoma.

The phase 3 PALLAS trial exploring palbociclib (Ibrance) in patients with HR-positive, HER2-negative early breast cancer is unlikely to demonstrate a statistically significant improvement in the study’s primary end point of invasive disease-free survival.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non–small cell lung cancer not previously treated with ROS1 inhibitors.

RET inhibitor pralsetinib induced responses in a number of patients with rare and difficult to treat RET fusion–positive solid tumors.

MGD013, an investigational DART protein targeting PD-1 and LAG-3, demonstrated encouraging monotherapy activity as well as in combination with margetuximab in multiple tumor types.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the PI3K inhibitor alpelisib for use in combination with fulvestrant as treatment for patients with breast cancer.

The FDA has approved the combination of ramucirumab and erlotinib as a frontline treatment for patients with metastatic non–small cell lung cancer whose tumors harbor EGFR mutations.

The FDA has approved atezolizumab plus bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Maintenance niraparib improved progression-free survival in Chinese patients with recurrent ovarian cancer who were in a complete or partial response to platinum-based chemotherapy, meeting the primary end point of the phase 3 NORA study.

The National Comprehensive Cancer Network has updated its Prostate Cancer guidelines to include the PARP inhibitor rucaparib.

The FDA has granted Fast Track designation to onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

The FDA’s Oncologic Drugs Advisory Committee will no longer be meeting to review a Biologics License Application for margetuximab for the treatment of patients with HER2-positive breast cancer.

Atezolizumab in combination with carboplatin and etoposide has been approved in the UK for the frontline treatment of patients with extensive-stage small cell lung cancer.

The rate of global molecular testing is low and is limited by a number of factors, including cost, quality, turn-around time, access, and lack of awareness of testing.

The FDA has approved nivolumab combined with ipilimumab and chemotherapy for use as a frontline treatment for patients with metastatic or recurrent non–small cell lung cancer.

Gilberto de Lima Lopes, MD, discusses the appropriate duration of immunotherapy in lung cancer, treatment-related adverse events, and remaining challenges faced in the space.

The FDA has granted a Fast Track designation to CLR 131 for use as a treatment for patients with lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia.

R. Lor Randall, MD, FACS, discusses the cautions medical oncologists should take for their patients with bone sarcomas who undergo limb preservation with osteointegration, and the importance of keeping orthopedic oncologists in the loop.

Raymond Liu, MD, shed light on the benefits and challenges of utilizing telehealth in oncology and shared advice on how to implement this approach in practice.

Decreases in local-stage and increases in distant- and regional-stage prostate cancer incidence may be the result of a recommendation by the US Preventive Services Task Force against PSA–based screenings.

The UK's National Institute for Health and Care Excellence has recommended the combination of atezolizumab and nab-paclitaxel as a treatment for patients with unresectable, locally advanced, or metastatic triple-negative breast cancer whose tumors express PD-L1 at a level of 1% or more and have not had prior chemotherapy for metastatic disease.

The combination of entinostat and exemestane did not show a statistically significant improvement in overall survival compared with exemestane alone in patients with advanced hormone receptor—positive, HER2-negative breast cancer who have progressed on a nonsteroidal aromatase inhibitor, missing the primary endpoint of the phase 3 E2112 trial.

The FDA has approved brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer, as detected by an FDA-approved test.

Lajos Pusztai, MD, DPhil, discusses the results from the I-SPY 2 trial, as well as the clinical implications of the findings.