News

In patients with muscle-invasive bladder cancer treated in the phase 2 HCRN GU16-257 trial, the combination of transurethral resection of the bladder tumor with nivolumab and chemotherapy showed promise.

An analysis of the phase 3 CheckMate 9ER trial revealed that cabozantinib exposure did not significantly correlate with progression-free survival but appeared to predict high rates 2 specific adverse events.

The FDA has granted fast track designation to bemcentinib in combination with an anti-PD-L1 agent as a potential treatment option for patients with AXL-positive advanced or metastatic non-small cell lung cancer.

Results from the phase 2 LTHAIC study showed that adding toripalimab and hepatic arterial infusion chemotherapy to lenvatinib achieved robust and durable responses in patients with advanced hepatocellular carcinoma.

The FDA has extended the review period of the supplemental new drug application for ruxolitinib as treatment of patients aged 12 years or older with steroid-refractory chronic graft-versus-host disease.

The FDA has granted the expanded use of ravulizumab-cwvz to include the treatment of children aged 1 month and older and adolescents with paroxysmal nocturnal hemoglobinuria.

Lisaftoclax, a novel BCL-2 inhibitor, has demonstrated encouraging responses with acceptable safety in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, and other hematologic cancers who were treated in first-in-human phase 1 trial.

Data from the phase 3 AGO-OVAR 17/BOOST/GINECO OV118/ENGOT Ov-15 trial of patients with primary epithelial ovarian, fallopian tube, or peritoneal cancer show that even though prolonged treatment with bevacizumab is feasible and safe, it does not improve survival.

Results from the final analysis of the phase 1b FORWARD II trail, show that mirvetuximab soravtansine combined with bevacizumab yielded durable responses in patients with recurrent, platinum agnostic ovarian cancer, a population with an unmet need for more effective, non-platinum treatments.

Data presented at the 2021 virtual ASCO Annual Meeting showed the benefits of adding nivolumab to chemotherapy treatment compared to chemotherapy alone, in patients with resectable non-small cell lung cancer.

New results, presented at the 2021 ASCO annual meeting, show the benefit of adding durvalumab to neoadjuvant anthracycline and taxane–based chemotherapy for patients with early triple-negative breast cancer.

A small clinical trial of pediatric patients with relapsed/refractory acute myeloid leukemia showed efficacy and safety with anti-C-type lectin-like molecule-based chimeric antigen receptor T cells.

Overall survival was not improved with alectinib in patients with treatment-naïve, advanced ALK-positive non-small cell lung cancer, compared to crizotinib.

Increased efficacy was observed with the combination of mosunetuzumab with polatuzumab vedotin in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Treatment with aumolertinib led to improved progression free survival and duration of response in patients with advanced non-small cell lung caner with epidermal growth factor receptor, compared with gefitinib.

In patients with relapsed/refractory diffuse large B-cell lymphoma treated with the triplet combinaton of polatuzumab vedotin, rituximab and lenalidomide, therapy was considered to be safe and effective.

treatment with patritumab deruxtecan induced clinically meaningful, durable efficacy in heavily pretreated patients with EGFR-mutated non–small cell lung cancer who were resistant to EGFR tyrosine kinase inhibitors.

Patients with previously treated non–small cell lung cancer harboring EGFR exon 20 insertion mutations showed promising preliminary anti-tumor activity and an acceptable safety profile across all of the doses tested in a phase 1 trial of CLN-081.

The combination of cirmtuzumab and ibrutinib achieved high overall response rates in patients with mantle cell lymphoma or chronic lymphocytic leukemia who were treated in a phase 1/2 study.

According to results from the phase 1/2 and phase 2 ALTA trials, brigatinib demonstrated sustained long-term responses and survival in patients with crizotinib-refractory ALK-positive non–small cell lung cancer.

The Association of Community Cancer Centers today announced the launch of the ACCC Community Oncology Research Institute.

Tremendous strides in science have led to a wave of precision medicine-based approaches for patients that consider each patient’s underlying genetics and what makes each patient’s cancer unique.

In a new survey from, a majority of oncologists are referring patients to CAR T-cell therapy but barriers to timely care still remain.

The phase 2 VERSATILE-002 trial of PDS0101 in combination with pembrolizumab for patients with advanced head and neck cancer has expanded to include those who have progressed on prior treatment with checkpoint inhibitors.

Treatment with daratumumab in community clinics appeared well tolerated in patients with multiple myeloma and showed similar efficacy to that observed in clinical trials.

A new drug application has been resubmitted to the FDA for Pedmark, a sodium thiosulfate formulation, for the prevention of ototoxicity induced by cisplatin-based chemotherapy in patients under the age of 18 years old with localized, non-metastatic solid tumors.

Joshua K. Sabari, MD, discusses the need for EGFR inhibitors designed specifically to treat patients with EGFR-mutant non–small cell lung cancer and an exon 20 insertion.

The FDA has approved Guardant360, a liquid biopsy companion diagnostic for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer who have a KRAS G12C mutation and may benefit from sotorasib.

The FDA has accepted and granted priority review to the new drug application for plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia in patients with cancer.

Here is a look back at the FDA happenings from the month of May 2021.