Kristi Rosa

The FDA has issued a complete response letter to Spectrum Pharmaceuticals regarding the biologics license application for eflapegrastimas a potential option for the management of chemotherapy-induced neutropenia.

Avapritinib did not improve progression-free survival vs regorafenib in patients with unresectable or metastatic gastrointestinal stromal tumors, but the agent continues to be the most active available option for a subset of patients with PDGFRA D842V–mutant disease.

The FDA has granted an orphan drug designation to sotigalimab as a potential therapeutic option for patients with soft tissue sarcoma.

The FDA has granted priority review to a supplemental biologics license application for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

The combination of cemiplimab-rwlc plus platinum-doublet chemotherapy was found to significantly improve overall survival over chemotherapy alone in the frontline treatment of patients with advanced non–small cell lung cancer, meeting the primary end point of the phase 3 EMPOWER-Lung 3 trial.

The FDA has granted a priority review designation to a supplemental new drug application for cabozantinib for the treatment of patients with differentiated thyroid cancer who have progressed after previous therapy and who are radioactive iodine refractory.

The combination of plinabulin plus docetaxel resulted in a statistically significant improvement in overall survival vs docetaxel alone when used in the second- or third-line treatment of patients with EGFR wild-type, non–small cell lung cancer and measurable lung lesions.

Bristol Myers Squibb has made the decision to withdraw in the indication for romidepsin as a monotherapy for the treatment of adult patients with peripheral T-cell lymphoma who have previously received at least 1 therapy.

The FDA has granted priority review to a supplemental biologics license application for atezolizumab as an adjuvant treatment after surgery and platinum-based chemotherapy in patients with non–small cell lung cancer whose tumors have a PD-L1 expression of 1% or higher per an FDA-approved test.

The FDA has granted a fast track designation to nemvaleukin alfa as a potential therapeutic option for patients with mucosal melanoma.

The combination of ivosidenib plus azacitidine significantly improved event-free survival compared with azacitidine plus placebo in previously untreated patients with IDH1-mutated acute myeloid leukemia, meeting the primary end point of the phase 3 AGILE trial.

Osimertinib has emerged as the standard of care for patients with EGFR-mutated non–small cell lung cancer, but the need for novel agents is underscored as disease progression on the agent is inevitable.

The FDA has granted a fast track designation to eryaspase for use as a potential therapeutic option in patients with acute lymphocytic leukemia who have developed hypersensitivity reactions to Escherichia coli–derived pegylated asparaginase.

Zanubrutinib resulted in a significant improvement in progression-free survival per independent review committee assessment vs bendamustine plus rituximab in treatment-naïve patients with chronic lymphocytic leukemia whose tumors did not exhibit the deletion of chromosome 17p13.1.

The European Commission has approved nivolumab for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after neoadjuvant chemoradiation.

The FDA has issued an alert that evidence from the phase 3 OCEAN study of melphalan flufenamide, which was recently approved for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma, has indicated that the doublet resulted in an increased risk of death in this population.

The addition of pembrolizumab to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs chemotherapy alone in patients with metastatic triple-negative breast cancer whose tumors had a PD-L1 expression of a combined positive score of 10 or higher, meeting the primary end point of the phase 3 KEYNOTE-355 trial.

The FDA has approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Health Canada has approved the BTK inhibitor zanubrutinib for use in the treatment of adult patients with mantle cell lymphoma who have previously received at least 1 therapy.

Roche Registration GmbH has withdrawn its application to extend the use of atezolizumab to the treatment of patients with early or locally advanced triple-negative breast cancer in Europe.

The FDA has granted priority review to a new drug application for the nanoparticle albumin-bound mTOR inhibitor nab-sirolimus for the treatment of patients with malignant perivascular epithelioid cell neoplasm.

The FDA has issued a complete response letter to Incyte Corporation stating that it cannot approve the biologics license application for retifanlimab for use in adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy, in its present form.

The combination of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine with and without consolidative radiotherapy was found to have strong efficacy and favorable tolerability in patients with early-stage, unfavorable-risk, Hodgkin lymphoma.

Bristol Myers Squibb has decided to voluntarily withdraw the indication for nivolumab as a monotherapy for patients with hepatocellular carcinoma who were previously treated with sorafenib from the US market.

The FDA has granted a regular approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, who have disease progression after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation.

The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.

The safety and efficacy of the oral MDM2 inhibitor milademetan is under investigation vs trabectedin, a current standard of care, in the treatment of patients with dedifferentiated liposarcoma as part of the recently initiated phase 3 MANTRA trial.

The FDA has granted a breakthrough therapy designation to the combination of venetoclax plus azacitidine for use in the treatment of adult patients with previously untreated, intermediate-, high-, and very high–risk myelodysplastic syndromes based on the revised International Prognostic Scoring System.

The CCR5 antagonist leronlimab plus carboplatin was shown to result in a 72% decrease in cancer-associated macrophage-like cells, which was linked with an approximate 450% increase in overall survival in 30 patients with metastatic triple-negative breast cancer.

The novel gene-mediated immunotherapy GEN-1 showcased satisfactory safety with an acceptable risk/benefit profile when given over a 6-month period with up to 17 doses in newly diagnosed patients with stage III/IV ovarian cancer.