News

The FDA approved Gallium 68 PSMA-11 as the first ever drug for PET imaging of PSMA positive lesions in men with prostate cancer.

ONCOS-102 plus pembrolizumab demonstrated promising objective responses as treatment of patients with anti-PD1–refractory malignant melanoma.

Here is a look back at the FDA happenings from the month of November 2020.

A once-per-week selinexor, bortezomib, plus dexamethasone treatment strategy appeared effective and convenient as treatment of patients with multiple myeloma who received at least 1 to 3 prior lines of therapy.

In an interview with Targeted Oncology, Pasi A. Jänne, MD, PhD, discussed the updated findings from the phase 1/2 study of mobocertinib as treatment of patients with non-small cell lung cancer who harbor an EGFR exon 20 insertions.

The FDA has accepted a New Drug Application for the oral FGFR1-3 selective inhibitor, infigratinib and granted it Priority Review for the treatment of patients with cholangiocarcinoma.

The FDA approved pralsetinib for the treatment of adult and pediatric patients who are 12 years old or older with advanced or metastatic RET-mutant medullary thyroid cancer and require systemic therapy.

The FDA has granted a Fast Track designation to the irinotecan liposome injection as a potential treatment option for patients with small cell lung cancer who progressed following a first-line platinum-based regimen, Ipsen announced, in a press release.

A rolling submission of a Biologics License Application to the FDA has been initiated for the combination of ublituximab plus umbralisib as treatment of patients with chronic lymphocytic leukemia .

The FDA accepted the New Drug Application from belumosudil and granted it a Priority Review designation for the treatment of patients with chronic graft-versus-host disease. The Prescription Drug User Fee Act target action date has been set to May 30, 2021.

The FDA granted a Fast Track designation to eprenetapopt as treatment of patients with TP53-mutant acute myeloid leukemia.

The FDA granted a Breakthrough Therapy designation to zanidatamab as treatment of patients with previously treated HER2-amplified biliary tract cancer.

A protocol has been filed with the FDA for a phase 2 clinical trial aimed to evaluate leronlimab, which has been used to treat various solid tumors and hematologic malignancies, as treatment of patients with coronavirus disease 2019 who are suffering from long-hauler symptoms.

The FDA has granted approval to the naxitamab as treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease on prior treatment.

The FDA granted a Fast Track designation to RV001 for the potential treatment of patients with prostate cancer.

New data show patients with mantle cell lymphoma who were treated with ibrutinib in a community setting had similar outcomes to patients given the Bruton’s tyrosine kinase inhibitor in a clinical trial setting, a retrospective study showed.

Low-dose ruxolitinib appears effective as treatment of patients with myelofibrosis, improving splenomegaly and symptoms with a daily dose ≤ 10 mg.

Investigators conducted post hoc analyses of the phase 3 JUMP clinical trial to determine how clinical characteristics correlate with response to therapy in patients with myelofibrosis.

Overall survival was statistically significantly improved with tebentafusp compared with investigator’s choice of therapy as treatment of patients with metastatic uveal melanoma in the phase 3 IMCgp100-202 study.

Investigators reported findings for 6 patients with mantle cell lymphoma who were treated in the ZUMA-2 clinical trial and progressed following treatment with therapy brexucabtagene autoleucel.

Results from the study were published in Blood and showed that obinutuzumab plus ibrutinib and venetoclax as treatment of patients with relapsed and untreated mantle cell lymphoma achieved high response rates with favorable tolerability.

The investigational drug Rhenium NanoLiposome demonstrated efficacy in an interim analysis presented at the 2020 Society for Neuro-Oncology Annual Meeting for patients with recurrent glioblastoma.

The FDA has accepted a Biologic License Application for loncastuximab tesirine as treatment of relapsed or refractory diffuse large B-cell lymphoma and granted it a Priority Review designation.

The FDA has approved an additional dosing option for the approved indications of durvalumab at a 1500-mg fixed dose administered every 4 weeks.

During Lung Cancer Awareness Month, David Spigel, MD, shared his insights on the evolving treatment paradigm in lung cancer and how the latest advances have impacted his treatment decisions for patients with lung cancer.

In an interview with Targeted Oncology, Chung-Han (Joe) Lee, MD, PhD, discussed the use of different targeted therapy and immunotherapy strategies for the treatment of patients with metastatic kidney cancer.

Active surveillance can be a safe and appropriate management strategy for patients with T1aN0M0 low-risk papillary thyroid microcarcinoma, though the decision to use the strategy requires multidisciplinary teams and patient input, according to a new report.

For the majority of patients with medullary thyroid cancer, vandetanib and cabozantinib are both effective treatment options, according to results from a retrospective analysis.

Following a long history with minimal advances, neoadjuvant therapy provides hope on future avenues to further explore in order to continue improving outcomes for patients with pancreatic cancer.

Patients of color who were diagnosed with lung cancer were associated with worse outcomes compared with Caucasian patients, according to findings from the 3rd Annual “State of Lung Cancer” Report by the American Lung Association.