News

The FDA granted a regenerative medicine advanced therapy designation to TSC-100 and TSC-101 for hematologic malignancies based on encouraging ALLOHA trial data, offering expedited development and review.

Over 8 years, dabrafenib and trametinib showed improved survival vs placebo in stage III melanoma, but overall and melanoma-specific benefits were not statistically significant.

The highest efficacy was observed in CP-CML patients harboring a BCR::ABL1 T315I mutation who received ponatinib at 45 mg daily.

The latest data on the combination of pelabresib and ruxolitinib in myelofibrosis may provide the rationale for a paradigm shift.

Puneeth Indurlal, MD, MS, discusses the implications of assessing for patients' health-related social needs during the course of cancer treatment at the 2024 ASCO Annual Meeting.

Zolbetuximab could become the first CLDN18.2-targeted therapy approved for this patient population in the US.

The FDA has granted a fast track designation to AGuIX, a gadolinium-based nanodrug currently under evaluation for treating malignant gliomas and glioblastoma.

Lorlatinib improved progression-free survival vs crizotinib when used as a treatment in patients ALK-positive non–small cell lung cancer.

Among patients with Ph-positive chronic phase chronic myeloid leukemia, asciminib demonstrated positive results, including a better major molecular response rate at 48 weeks vs investigator-selected TKIs.

Vikram Narayan, MD, discusses the significance of the 5-year overall survival and cystectomy-free survival rates of nadofaragene firadenovec-vncg in treating patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer.

The combination of camrelizumab and rivoceranib significantly improved survival rates in patients with unresectable liver cancer compared with standard treatment.

In an interview with Targeted Oncology, Paolo Ghia, MD, PhD, discussed the 5-year results from the CAPTIVATE study in chronic lymphocytic leukemia and/or small lymphocytic lymphoma.

The FDA has approved the CAR T-cell therapy liso-cel for the treatment of patients with mantle cell lymphoma.

The FDA has approved a phase 1, first-in-human trial to evaluate the safety and potential effectiveness of ACTM-838, a novel immunotherapy drug for advanced solid tumors.

A Prescription Drug User Fee Act target action date of September 25, 2024, has been set for the application of pembrolizumab plus chemotherapy in advanced mesothelioma.

In an interview with Targeted Oncology, Aleksander L. Chojecki, MD, discussed findings from his research on hematocrit control and thrombotic risk in patients with polycythemia vera treated with ruxolitinib.

AFM24 combined with atezolizumab has received a fast track designation from the FDA for treating advanced/metastatic non-small cell lung cancer without activating EGFR mutations.

A rolling new drug application is being submitted to the FDA for an ovarian cancer treatment combination of avutometinib and defactinib.

The approval of selpercatinib marks the first targeted therapy for pediatric patients with RET gene alterations in solid and thyroid tumors.

Zanidatamab could become the first FDA-approved, HER2-targeted treatment for HER2-positive biliary tract cancer.

While Dato-DXd numerically improved overall survival for patients with non-small cell lung cancer, the data did not show statistical significance. However, a clinically meaningful benefit was observed in a subgroup of patients.

As part of its Speaking Out video series, Howard D. Edington, MD, explores how oncolytic viruses are revolutionizing personalized cancer therapy, the challenges of interpreting vast genetic data, and the exciting potential of these targeted therapies.

An FDA advisory committee recommends approval for a new blood test for colorectal cancer screening, potentially offering a more convenient option that could boost screening rates.

Data from the phase 3 INAVO120 trial support the priority review granted by the FDA to inavolisib, palbociclib, and fulvestrant for the treatment of PIK3CA-mutated breast cancer.

In part 2 of our 3-part series, antibody-drug conjugates like enfortumab vedotin and tisotumab vedotin offer novel options for difficult-to-treat tumors.

Doris Hansen, MD, discusses the efficacy of daratumumab, lenalidomide, and dexamethasone vs bortezomib, lenalidomide, and dexamethasone in newly diagnosed myeloma.

In an interview with Targeted Oncology, Daniel Nguyen, MD, PhD, further discussed the findings from this phase 2 trial and the potential of vibecotamab.

Pembrolizumab combined with chemotherapy significantly improved overall survival in patients with high-risk early triple-negative breast cancer, according to the prespecified interim analysis of the phase 3 KEYNOTE-522 trial.

The FDA has set a target action date of September 27, 2024, for a decision on the supplemental biologics license application of isatuximab plus bortezomib, lenalidomide, and dexamethasone.

In part 1 of our 3-part series, antibody-drug conjugates are revolutionizing oncology, targeting cancer cells precisely. Agents like T-DM1, T-DXd, and sacituzumab govitecan continue to change the field.