News

American Oncology Network, LLC announces that Summit Cancer Centers, a leading cancer center in Spokane, Washington, has joined AON effective May 1, 2021.

A rolling submission of a new drug application to the FDA has been initiated for surufatinib as a potential treatment option for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

In an interview with Targeted Oncology, Ursula A. Matulonis, MD, discusses results from further follow-up of patients with ovarian cancer treated in the ENGOT-OV16/NOVA.

The combination of oleclumab and osimertinib was well-tolerated and demonstrated preliminary anti-tumor activity in patients with non-small-cell lung cancer with an EGFR mutation after progression on an EGFR tyrosine kinase inhibitor.

Here is a look back at the FDA happenings from the month of April 2021.

Experts discuss the treatment considerations for acute GVHD, the role of molecular testing, and considerations for steroid-refractory acute GVHD.

The experts discuss a case presentation of a 50-year-old woman with acute GVHD, risk factors for GVHD, and initial treatment options.

Jamile Shammo, MD, reviews initial treatment options for patients with low risk polycythemia vera.

Dr. Ruben Mesa and panel discuss the importance of and methods for risk assessment in patients with polycythemia vera.

Experts in MPN discuss diagnostic considerations for polycythemia vera.

Prithviraj Bose, MD, reviews the case of a 57-year-old man diagnosed with polycythemia vera.

The FDA has accepted a Biologics License Application for nivolumab for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and granted it Priority Review.

The FDA’s Oncologic Drug Advisory Committee voted 5 to 4 against the continued accelerated approval of nivolumab for the treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib.

In an 8 to 0 vote, the FDA’s Oncologic Drug Advisory Committee opted to continue to accelerated approval of pembrolizumab for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.

The FDA’s Oncologic Drugs Advisory Committee has voted 6 to 2 against the continued approval of pembrolizumab as indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 who experienced disease progression on or after 2 or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2-targeted therapy.

The use of zanubrutinib was found to be noninferior to treatment with ibrutinib for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, meeting the primary end point of the phase 3 ALPINE trial.

Thomas Marron, PhD, MD, discusses the need for effective neoadjuvant therapies in hepatocellular carcinoma.

The FDA’s Oncologic Drug Advisory Committee voted 10 to 1 to continue the accelerated approval of atezolizumab for the frontline treatment of patients with urothelial cancer who are ineligible for cisplatin.

The FDA’s Oncologic Drugs Advisory Committee voted 5 to 3 in favor of continued approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

The FDA has granted a priority review to mobocertinib as a treatment for adult patients with EGFR exon 20 insertion–mutant metastatic non–small cell lung cancer, as detected by an FDA-approved test, and who have received prior platinum-based chemotherapy.

The FDA's Oncologic Drugs Advisory Committee voted 7 to 2 in favor of the continued approval of atezolizumab in combination with nab-paclitaxel for the treatment of patients with advanced or metastatic triple-negative breast cancer whose tumors are positive for PD-L1 expression.

The FDA has granted orphan drug designation to ITIL-168 for the treatment of stage IIB to IV melanoma, an investigational, autologous cell therapy derived from tumor-infiltrating lymphocytes.

Results from the phase 2 study of farnesyltransferase inhibitor tipifarnib showed significant responses in patients with recurrent and/or metastatic head and neck squamous cell carcinoma and demonstrated that variant alle frequency could be a potential biomarker in this patient population.

Continued data for the first-generation BTK inhibitor have demonstrated its expanding utility amid a growing treatment arsenal.

Both KRAS and EGFR mutations have become increasingly important targets in non–small cell lung cancer. This is especially remarkable as KRAS was once considered an “untargetable mutation.”

Treatment with the tyrosine kinase inhibitor entrectinib may lead to continued clinical benefit as treatment of patients with ROS1-positive non–small cell lung cancer, including those with central nervous system metastases, according to an updated from an integrated analysis of 3 clinical trials.

The FDA has removed the clinical hold on the investigational new drug application of NL-201, a treatment for relapsed or refractory tumors, allowing a phase 1 clinical trial to begin.

In patients with advanced clear cell renal cell carcinoma, a phase 1b/2 umbrella platform study is evaluating the safety and efficacy of experimental combinations of investigational agents.

In an interview with Targeted Oncology, Scott R. Solomon, MD, a medical oncologist with the Blood and Marrow Transplant Program, Leukemia and Cellular Immunotherapy Program at the Northside Hospital Cancer Institute, discussed the efficacy of liso-cel in large B-cell lymphoma patients with prior anti-CD19 exposure and future research.

The FDA has been leading an industry-wide evaluation of accelerated approvals of oncology drugs for which the clinical benefit was not verified in confirmatory trials.