News

Naval G. Daver, MD, discusses the latest research on magrolimab, a CD47 monoclonal antibody, for patients with acute myeloid leukemia and myelodysplastic syndrome.

Results from the phase 3 TRITON3 study show that rucaparib improves survival in multiple metastatic castration-resistant prostate cancer populations.

Future directions for follicular lymphoma treatments include potential use earlier in treatment or as combination therapy, identifying patients who will benefit most from treatment, and minimizing the costs of therapy while maximizing accessibility.

After results from a phase 2 trial demonstrated durability with sapanisertib, the FDA granted fast track designation to the agent for patients with unresectable or metastatic squamous non–small cell lung cancer.

Building on data showing its preclinical anti-tumor activity, CUE-101 will be examined in a phase 1b study and has been granted FDA fast track designation.

Melissa M. Hardesty discusses the key takeaways of the phase 2 OVARIO study of a PARP inhibitor plus a VEGF inhibitor in women with advanced ovarian cancer as well as research still needs to examine in this space.

In an interview with Targeted Oncology, Peter A. McSweeney discussed the ways in which community oncology centers are implementing chimeric antigen receptor T-cell therapy into their practice and the challenges that come with it.

Results from the phase 3 Study 302 of denileukin diftitoc in patients with persistent of recurrent cutaneous T-cell lymphoma led to the submission of a biologics license application for the drug.

Here is a look back at the FDA happenings from the month of September 2022

To determine the effectiveness of nirogacestat at 150mg twice a day in patients with ovarian granulosa cell tumors, the agent has been administered to the first patient in a phase 2 trial.

Traditionally, MCL was dichotomized based on the age of the patient and their ability to tolerate intensive therapy, [but] now we have to take into consideration biological differences across patients that go well beyond age, says Andre H. Goy, MD.

Results from the POLARIX clinical trial support the use of polatuzumab vedotin plus rituximab as frontline treatment for diffuse large B-cell lymphoma.

Findings from the TAS-120-101 study have led the FDA to approve futibatinib for the treatment of patients with FGFR2-positive advanced cholangiocarcinoma.

The FDA has approved bevacizumab-abcd for use in nonsquamous non–small cell lung cancer, recurrent glioblastoma, metastatic colorectal cancer, persistent, recurrent, or metastatic cervical cancer, metastatic renal cell carcinoma, and epithelial ovarian, fallopian tube, and primary peritoneal cancer.

The humanized monoclonal antibody JSP191 showed an 100% complete donor chimerism and resulted in no treatment-related adverse events when administered to patients with Fanconi anemia.

Melhem Solh, MD, discusses his research on post-transplant outcomes of patients with TP53-mutant acute myeloid leukemia and myelodysplastic syndrome.

In an interview with Targeted Oncology following the tweet chat, Cyrus M. Khan, MD, discussed the emerging and recent data he thinks could influence the case we discussed.

Based on preclinical studies which have shown the clinical benefit of Olvi-Vec, a phase 3 trial evaluating the agent in combination with platinum-doublet chemotherapy and bevacizumab has commenced in patients with platinum-resistant/refractory ovarian cancer.

Pain is a clinical challenge for many oncology patients and clinicians, and there's a growing body of evidence showing that integrative therapies can be useful in pain management, according to Heather Greenlee, ND, PhD.

Pertuzumab plus trastuzumab and chemotherapy remains the standard of care for HER2-positive breast cancer, after the addition of atezolizumab did not benefit responses in the Impassion050 study.

A 5-year overall survival analysis led the FDA to question duvelisib for relapsed or refractory chronic lymphocytic leukemia. ODAC members voted that the benefit-risk profile of the drug is not favorable.

Due to the potential detriment in overall survival, its failure to demonstrate a progression-free survival benefit, and the lack of a known appropriate dose, ODAC has voted that melphalan flufenamide is not favorable in relapsed/refractory multiple myeloma.

Based on the efficacy, toxicity, dose-optimization, and lack of confirmatory data for poziotinib in HER2 exon 20 insertion-positive non–small cell lung cancer, ODAC has voted that the drug has an unfavorable risk/benefit profile.

Jonathan E. Rosenberg, MD, discusses what the frontline treatment landscape for metastatic urothelial cancer currently looks like.

Following a report of impressive 2-year follow-up data, the FDA has granted a regular approval to selpercatinib.

Alexander Drilon, MD, discusses what community oncologists should know about testing for  NTRK gene fusions in patients with solid tumors.

Enrollment has begun in the phase 1b trial examining PY159 alone and in combination with pembrolizumab in patients with unresectable and/or metastatic solid tumors that are refractory or relapsed to standard of care.

The FDA has granted approval to Pedmark to reduce the risk of ototoxicity associated with cisplatin in pediatric patients.

Distinguishing on current imaging between disease progression and pseudo progression in patients with glioblastoma is one of the most difficult clinical problems, according to Manmeet Ahluwalia, MD and Pallavi Tiwari, PhD.

Findings of the phase 2 LCMC3 trial of atezolizumab in untreated, resectable, stage IB–IIIB non–small cell lung cancer show anti-PD-L1 monotherapy to be effective in this patient population.