Jordyn Sava

The FDA has requested additional information regarding vic-trastuzumab duocarmazine to further evaluate the agent for patients with HER2-positive metastatic breast cancer.

Adult patients with chronic lymphocytic leukemia had significantly better minimal residual disease and progression-free survival results when treated with venetoclax and obinutuzumab or venetoclax, obinutuzumab, and ibrutinib vs standard chemoimmunotherapy

Positive findings from the FLAURA2 study add to the body of evidence supporting treatment with osimertinib for patients with EGFRm non–small cell lung cancer.

The fast track designation to IMPT-314 is for the treatment of multiple types of B-cell lymphoma in patients who previously received 2 or more lines of systemic therapy.

The FLASH study and compatibility study of SGX301 led to promising safety and efficacy responses for the treatment of cutaneous T-cell lymphoma. Now, the FDA has granted a type A meeting to discuss the design of a second trial of SGX301.

In an interview, Ruben Mesa, MD, discussed the currently available JAK inhibitors for patients with myelofibrosis, and what is in store for the field.

The phase 3 RATIONALE-306 study displayed encouraging survival and safety data among patients with advanced or metastatic esophageal squamous cell carcinoma who were treated with tislelizumab and chemotherapy.

The proportion of patients with myelodysplastic syndromes who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for patients given roxadustat vs 33.3% for patients given placebo for the treatment of anemia.

A study of patients with relapsed/refractory diffuse large B-cell lymphoma has showed that continuous administration of PD-1 inhibitors as a maintenance treatment may be feasible to maintain the efficacy of anti-CD19-CAR T cells.

ACR-368 generated deep and durable responses across several phase 2 studies. The agent has now been granted fast track designations for patients with platinum-resistant ovarian cancer and endometrial cancer.

FDA approval has not been granted to N-803 for the treatment of Bacillus Calmette–Guérin-unresponsive non-muscle-invasive bladder cancer carcinoma in situ.

Significant differences in the incidence of genitourinary events, depression, and ischemic and thrombotic events were observed based on race among patients with prostate cancer after receiving androgen deprivation therapy.

The new DNA methylation-based PDACatch assay has received a breakthrough device designation from the FDA to detect patients at high-risk for pancreatic adenocarcinoma.

According to findings from an integrated BIM, single treatment with selpercatinib had a little impact on third-party payers’ formulary budgets for patients with RET-altered solid tumors.

Two genetically engineered gamma-delta T-cell therapies, INB-400 and INB-410, have been granted an orphan drug designation from the FDA for numerous types of malignant glioma.

Treatment with lurbinectedin is cost-effective as a second-line treatment for patients with metastatic small cell lung cancer who have had disease progression on or after platinum-based chemotherapy.

Adjuvant chemotherapy did not lead to survival improvements vs standard chemoradiotherapy alone in patients with locally advanced cervical cancer and resulted in more severe adverse events, according to OUTBACK trial data.

In an interview with Targeted Oncology, Adam J. Olszewski, MD, discussed mosunetuzumab and the rationale and findings of this phase 1b/2 study assessing the agent in elderly patients with diffuse large B-cell lymphoma.

Patients with recurrent or metastatic squamous cell carcinoma of the head and neck did not derive an overall response rate benefit with nivolumab and ipilimumab vs nivolumab alone.

The FoundationOne® Liquid CDx has been granted approval by the FDA as a companion diagnostic for mobocertinib for patients with locally advanced or metastatic non–small cell lung cancer harboring an EGFR exon 20 insertion mutation.

Impressive efficacy data and consistent safety data continue to be seen with mirvetuximab soravtansine for the treatment of patients with platinum-resistant ovarian cancer, according to data from the confirmatory MIRASOL trial.

In an interview with Targeted Oncology, Mitchell Smith, MD, PhD, discussed what the findings from the ECOG-ACRIN E1411 trial in patients with mantle cell lymphoma means for the future of the space, and where research is heading.

TPST-1120 shows promising efficacy and safety data in a phase 1b/2 study of the agent among patients with unresectable or metastatic hepatocellular carcinoma.

The TRANSCEND FL and TRANSCEND NHL 001 studies of lisocabtagene maraleucel met its primary end point of overall response rate and secondary end point of complete response rate in patients with follicular lymphoma and B-cell non-Hodgkin lymphoma.

Treatment with TARA-002 at 3 different dose levels was generally well-tolerated, and no dose limiting toxicities were observed among patients with high-grade non-muscle invasive bladder cancer.

Here is a look back at all of the FDA happenings from April 2023.

Findings from the COMMANDS study in which luspatercept showed statistically significant and clinically meaningful improvements for patients with low-risk myelodysplastic syndrome, the FDA has set a target action date of August 28, 2023.

The combination of lenvatinib and pembrolizumab continued to show benefits in efficacy vs chemotherapy among patients with endometrial cancer treated in Study 309/KEYNOTE-775.

In an interview with Targeted Oncology, Ken Kato, MD, PhD, discussed background and findings from the phase 3 CheckMate 648 trial among patients with esophageal squamous cell carcinoma.