Kristi Rosa

The FDA has granted an orphan drug designation to LP-184 as a potential therapeutic option for patients with pancreatic cancer.

The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy as frontline options for adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The FDA has granted an orphan drug designation to the allogeneic CAR T-cell therapy ALLO-715 for the treatment of patients with multiple myeloma.

The FDA has granted an orphan drug designation to CFT7455 for use as a potential therapeutic option in patients with multiple myeloma.

COVID-19 vaccination has been shown to induce high rates of seroconversion in patients with cancer, although those with hematologic malignancies have demonstrated lower immunogenicity and those who previously received immunosuppressive therapies appear to be less responsive.

The FDA has granted a fast track designation to IN10018 as a potential therapeutic option for use in patients with platinum-resistant ovarian cancer.

Sintilimab plus oxaliplatin/capecitabine significantly improved overall survival over chemotherapy alone when used as a first-line treatment in patients with unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA has issued a complete response letter to Sesen Bio regarding its biologics license application for Vicineum for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

The FDA has approved belzutifan for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors that do not require immediate surgery.

The FDA has granted a breakthrough therapy designation to toripalimab for single-agent use in combination with gemcitabine and cisplatin in the frontline treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The FDA has approved pembrolizumab plus lenvatinib for the frontline treatment of adult patients with advanced renal cell carcinoma.

The subcutaneously administered peptide cancer vaccine maveropepimut-S was found to produce promising activity in heavily pretreated patients with recurrent ovarian cancer.

The FDA has accepted a new supplemental biologics license application that is seeking the approval of pembrolizumab for use as a monotherapy in patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair deficient, who have progressed after systemic therapy in any setting and are not eligible for curative surgery or radiation.

After a dramatic decrease during the first peak of the COVID-19 pandemic, a substantial increase in cancer screening procedures during more recent time periods has been reported.

The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab as an adjuvant treatment in patients with renal cell carcinoma.

The FDA has finalized guidance on the use of metastasis-free survival as an end point in clinical trials for nonmetastatic castration-resistant prostate cancer.

Polatuzumab vedotin-piiq in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone resulted in a statistically significant and clinically meaningful improvement in progression-free survival vs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with diffuse large B-cell lymphoma.

Fam-trastuzumab deruxtecan-nxki significantly improved progression-free survival over ado-trastuzumab emtansine in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane, meeting the primary end point of the phase 3 DESTINY-Breast03 trial.

The FDA has placed a partial clinical hold on clinical trials examining the combination of eprenetapopt and azacitidine in patients with myeloid malignancies.

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.