Gina Columbus

Enfortumab vedotin-ejfv combined with pembrolizumab led to an objective response rate of 73% in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin-based chemotherapy.

The FDA has granted a final approval to pemetrexed for injection, an alternative to standard pemetrexed, for the treatment of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer and for those with malignant pleural mesothelioma.

The FDA has granted a priority review designation to a biologics license application for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application for avapritinib as a treatment for adult patients with fourth-line gastrointestinal stromal tumor.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

The European Medicines Agency has validated a Marketing Authorization Application for belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor, and a CD38-directed monoclonal antibody.

The addition of dinutuximab injection to irinotecan did not improve overall survival compared with irinotecan or topotecan alone in patients with relapsed/refractory small cell lung cancer, missing the primary endpoint of the phase II/III DISTINCT trial.

Bristol-Myers Squibb has withdrawn its application in the European Union for the frontline combination of nivolumab and ipilimumab as a treatment for patients with advanced non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the fixed-dose combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia.

The European Medicines Agency has validated a Marketing Authorization Application for tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have received ≥2 prior anti-HER2 treatment regimens.

The FDA has granted a breakthrough therapy designation to the combination of APR-246 and azacitidine for the treatment of patients with myelodysplastic syndromes with a susceptible TP53 mutation.

R. Lor Randall, MD, discusses the referral challenges for orthopedic oncologists and the importance of improving quality of life for patients with metastatic bone disease.

Darolutamide plus androgen deprivation therapy (ADT) led to a significant improvement in overall survival (OS) compared with placebo and ADT in patients with nonmetastatic castration-resistant prostate cancer, according to results from a preplanned final OS analysis of the phase III ARAMIS trial.

A new drug application has been filed with the Japanese Ministry of Health, Labor and Welfare for manufacturing and marketing approval of cabozantinib for the treatment of patients with unresectable hepatocellular carcinoma following progression on prior systemic therapy.

The European Medicines Agency has validated and is now evaluating a Marketing Authorization Application for the CAR T-cell therapy KTE-X19 for the treatment of adult patients with relapsed/refractory mantle cell lymphoma.

The FDA has granted a priority review designation to a new drug application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion–positive non–small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion–positive thyroid cancer.

A supplemental biologics license application has been submitted to the FDA for the combination of atezolizumab and bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

Adjuvant treatment with atezolizumab did not significantly improve disease-free survival compared with observation in patients with muscle-invasive bladder cancer, missing the primary endpoint of the phase III IMvigor010 trial.

The FDA has granted an accelerated approval to tazemetostat for the treatment of adult and pediatric patients aged ≥16 years old with metastatic or locally advanced epithelioid sarcoma that is not eligible for complete resection.

China’s State Administration of Drug Administration has approved ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease following a neoadjuvant trastuzumab-based regimen.

The United Kingdom’s National Institute for Health and Care Excellence will not recommend osimertinib as a frontline treatment for patients with locally advanced or metastatic EGFR-mutant non–small cell lung cancer.

A DNA methylation-based cell-free DNA assay demonstrated high specificity and accurate localization of cancers to specific regions of the gastrointestinal tract.

The European Commission has granted marketing authorization for daratumumab in combination with bortezomib, thalidomide, and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

The European Commission has granted a conditional marketing authorization to polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for hematopoietic stem cell transplant.

Surufatinib improved progression-free survival compared with placebo in patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumors for whom there is no effective therapy.

The FDA has granted an orphan drug designation to durvalumab and tremelimumab for the treatment of patients with hepatocellular carcinoma.

The FDA has granted a priority review designation to a biologics license application for belantamab mafodotin as a treatment for patients with relapsed/refractory multiple myeloma who received prior therapy with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

The anti–PD-1 agent tislelizumab (BGB-A317) in combination with chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with advanced squamous non–small cell lung cancer.

The FDA has granted a priority review designation to a supplemental new drug application for olaparib (Lynparza) for the treatment of patients with metastatic castration-resistant prostate cancer who have deleterious or suspected deleterious or somatic homologous recombination repair gene mutations, and who have also progressed on prior therapy with a new hormonal agent.