Nichole Tucker

In lung cancer, the historic absence of clear biomarkers to identify patients who could derive benefit from MET-specific therapy has kept the field from moving forward with potential therapies.

Regardless of HER2 status, patients with human leukocyte antigen-A02, node-positive and high-risk node-negative breast cancer, had significant improvement in responses with a GP2 peptide vaccine plus GM-CSF compared with GM-CSF alone.

The relapse-free survival benefit observed with rituximab maintenance added to autologous stem cell transplant suggests that the treatment strategy may help with disease eradication.

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.

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.

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 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.

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 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.

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.

Avelumab is considered a new standard-of-care treatment for patients with advanced urothelial carcinoma who have not progressed on frontline platinum-containing chemotherapy after the agent demonstrated overall survival improvement for this patient population in a phase 3 clinical trial setting.

When given at the recommended phase 2 dose, lenzilumab in combination with taxicabtagene ciloleucel, induced a 100% objective response rate while showing no severe cytokine release syndrome cases or severe neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma.

The FDA has granted priority review to the sterile injectable therapy SH-111 for the treatment of pediatric patients with T-cell leukemia.

The FDA has granted accelerated approval to dostarlimab-gxly for the treatment of adult patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR, as determined by an FDA approved test.

A novel liquid biopsy test for the detection of lymph node metastasis in individuals with high-risk submucosal colorectal carcinoma has been developed.

The first large study of Black patients receiving immune checkpoint inhibitors is underway to uncover differences in response to immunotherapy in Black patients compared with White patients.

In the phase 1/2 AUGMENT-101 clinical trial, treatment with the novel menin-MLL small molecule inhibitor SNDX-5613 led to robust clinical responses in patients with mixed lineage leukemia rearranged and NPM1c-mutant relapsed or refractory acute leukemias.

The FDA has granted a regenerative medicine advanced therapy designation to the allogeneic chimeric antigen receptor T-cell therapy ALLO-715 for the treatment of relapsed or refractory multiple myeloma,.

According to a new study, marital status and education level may impact treatment and overall outcomes for patients with mantle cell lymphoma.

The FDA has granted breakthrough therapy designation to bemarituzumab for the first-line treatment of patients with HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma who harbor FGFR2b overexpression or amplification.

The FDA has granted an orphan drug designation to CA-4948, a first-in-class, small-molecule inhibitor of IRAK4, for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome.

The FDA has lifted a partial clinical hold on a phase 1 clinical trial of SBP-101 in combination with the standard-of-care agents gemcitabine and nab-paclitaxel as treatment of patients with metastatic pancreatic ductal adenocarcinoma.

In patients with breast cancer, who were predominantly hormone receptor–positive, 37.8% had a conversion to HER2-positive status that led to significant benefit from frontline treatment with taxane-trastuzumab with or without pertuzumab.

Pirtobrutinib showed promising efficacy and safety as treatment of patients with mantle cell lymphoma, demonstrating the potential to serve an unmet medical need.

The FDA has granted a rare pediatric disease designation to the novel p-STAT3 inhibitor WP1066 for the treatment of patients with the rare brain and spinal cord malignancy, ependymoma.

In patients with desmoid tumors, tegavivant has demonstrated early safety and tolerability.

The addition of parsaclisib to ruxolitinib led to improvement in spleen volume reduction and symptom burden in patients with myelofibrosis who had a suboptimal response on a standard dose of ruxolitinib alone, according to results from a phase 2 study.

According to a retrospective analysis presented during the 2021 European Lung Cancer Congress, earlier diagnosis and biomarker testing should be more widely implemented to identify patients with EGFR-positive non–small lung cancer who may benefit for EGFR inhibition.

Treatment with pembrolizumab led to improvement in disease-free survival in patients with renal cell carcinoma following nephrectomy or following nephrectomy and resection of metastatic lesions, meeting the primary end point of the pivotal phase 3 KEYNOTE-564 trial.