News

Within 60 days, the FDA will make a decision on whether to accept the biologics license application for omidubicel as treatment for patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant.

A fast track designation has been granted by the FDA to the combination of PDS0101 and pembrolizumab, an investigational regimen for the treatment of patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma.

The FDA has withdrawn its approval for the umbralisib, which had previously been approved for marginal zone lymphoma and follicular lymphoma.

RV001 did not show superiority to placebo in terms of preventing progression of disease in patient with prostate cancer.

In an interview with Targeted Oncology, Manali Kamdar, MD, discussed the current relapsed/refractory B-cell non-Hodgkin lymphoma space, along with data from the phase 1 clinical trial of an anti-CD19 CAR T-cell product for these patients.

In an interview with Targeted Oncology, William J. Catalona, MD, reviewed the history of active surveillance in the prostate cancer space and how the practice has become more widespread in the United States.

Here’s a look back at all of the FDA happenings from May 2022.

Allegheny Health Network Cancer Institute will be collaborating with Illumina to evaluate the impact of in-house comprehensive genomic profiling to enhance patient care.

Matthew J. Matasar, MD, discusses the current landscape of diffuse large B-cell lymphoma.

Andreas Saltos, MD, discussed treatment options for EGFR and KRAS-mutated NSCLC, and the investigational use of binimetinib to treat these tumors.

The combination of naxitamab combined with irinotecan, temozolomide, and sargramostim induced responses in patients with high-risk neuroblastoma.

The FDA has approved pegfilgrastim-pbbk, a biosimilar product referencing Neulasta.

The FDA has granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed/refractory follicular lymphoma after receiving 2 or more lines of systemic therapy.

Patients were diagnosed with prostate cancer at the expected average age with a majority of individuals diagnosed with stage 1 or 2 disease, and a significant minority presented with metastases.

In an interview with Targeted Oncology, Neal Shore, MD, FACS, discussed the use of enzalutamide plus androgen deprivation therapy in metastatic hormone sensitive prostate cancer and how post-hoc findings from the ARCHES study can be applied to practice.

Charles Geyer, MD, discusses the end point that was met within the OlympiA study.

Thomas Habermann, MD, discusses the unmet clinical needs which still exist for patients with diffuse large B-cell lymphoma.

The FDA has granted approval to nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.

A new report from ASCO and the ACCC provides recommendations on how to better represent a wider range of patients from different backgrounds, preferences, and identities within the clinical trial setting.

In patients with advanced non-squamous non–small cell lung cancer treated within large community health systems in the United States , biomarker testing appeared to be significantly higher compared with independent community practices, research shows.

The FDA has lifted the partial clinical hold on the phase 1 NEON-2 trial of davoceticept plus pembrolizumab in adult patients with advanced solid tumors or lymphoma.

Allegheny Health Network and Illumina, Inc. announced a collaborative effort to assess their in-house comprehensive genomic testing to analyze the role of genetic tests in improving cancer care.

GEMSTONE-301 showed sugemalimab to demonstrate a statistically significant and clinically meaningful improvement in progression-free survival in patients with unresectable stage 3 non-small cell lung cancer without disease progression after concurrent or sequential chemoradiotherapy.

In an interview with Targeted Oncology following the tweet chat, Omid A. Hamid, MD, discussed the key takeaways from the discussion, including the ways he would treat the patient discussed in the case.

The FDA has granted approval for ivosidenib tablets as treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia.

Valencia Thomas, MD, MHCM, discusses how the management of care for patients with non-melanoma skin cancers has changed over the past decade.

A biologics license application has been submitted to the FDA for N-803 plus Bacillus Calmette-Guérin as treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer in situ with or without Ta or T1 disease.

With an FDA fast track designation in tow, seribantumab is now under investigation in a phase 2 study of patients with advanced solid tumors.

Patients with tumors harboring PIK3CA mutations reported a better objective response rate when given copanlisib compared to those with the null hypothesis.