Chris Ryan

The FDA has approved the FoundationOne® CDx for use as a companion diagnostic to identify patients with advanced hormone receptor–positive, HER2-negative advanced breast cancer who may be eligible for treatment with the combination of capivasertib and fulvestrant.

The addition of bemcentinib to the standard-of-care therapies of pembrolizumab or dabrafenib plus trametinib was well tolerated in patients with metastatic melanoma; however, it did not lead to improvements in overall response rate, progression-free survival, or overall survival vs SOC alone.

The FDA’s Oncologic Drugs Advisory Committee will meet to review data from the supplemental biologics license application seeking the approval of idecabtagene vicleucel for use in earlier lines of treatment for patients with triple-class exposed relapsed/refractory multiple myeloma.

Interrupting combination treatment with axitinib and avelumab and switching to avelumab maintenance after a response at 36 weeks led to a decrease in treatment-related toxicities and delayed tumor progression in previously untreated patients with metastatic clear cell renal cell carcinoma.

The FDA has approved enzalutamide for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

The FDA has approved capivasertib plus fulvestrant for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alterations, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

The FDA has approved pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Data from a real-world study in Japan showed that fam-trastuzumab deruxtecan-nxki displayed intracranial efficacy in patients with HER2-positive breast cancer harboring brain metastases and/or leptomeningeal carcinomatosis.

The use of the optical imaging agent FG001 led to the detection of additional cancer by optical guidance in patients with high-grade glioma, meeting the primary end point of the phase 2b FG001-CT-001 trial.

Treatment with the novel immunotherapy PV-10 led to hepatic responses in patients with metastatic uveal melanoma with liver metastases, according to updated data from a phase 1 trial.

Additional research exploring the association between clonal hematopoiesis and cardiovascular health could help improve outcomes for patients with kidney cancer and identify those at higher risk for experiencing cardiac events.

The combination of enfortumab vedotin-ejfv plus pembrolizumab represents a chemotherapy-free regimen that could alter the standard of care in the frontline treatment of all patients with metastatic urothelial carcinoma.

The mitigation and management of toxicities is a key component of treating patients with biliary tract cancers with targeted therapies.

Along with the combination of venetoclax and obinutuzumab, the BTK inhibitor–based regimens of zanubrutinib monotherapy and acalabrutinib plus obinutuzumab represent the preferred options in the National Comprehensive Cancer Network Guidelines for the first-line treatment of patients with chronic lymphocytic leukemia without 17p deletions or TP53 mutations.

The combination of domvanalimab, zimberelimab, and FOLFOX elicited responses in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, irrespective of PD-L1 status.

First-line treatment with the PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine led to a statistically significant improvement in overall survival vs placebo plus oxaliplatin and capecitabine in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, meeting the primary end point of the phase 3 AK104-302 trial.

The FDA has cleared the investigational new drug application for CHM 2101, a novel CDH17-targeted CAR T-cell therapy, for the treatment of patients with gastrointestinal cancers.

The addition of panitumumab to FOLFIRINOX or mFOLFOX6 led to comparable overall response rates and complete response rates in patients with RAS or BRAF V600E wild-type, unresectable, metastatic colorectal cancer without liver-limited disease.

The FDA has granted an orphan drug designation to AL102 as a potential therapeutic option for patients with desmoid tumors.

Improved toxicity, advanced technology, and novel techniques have helped increase the use of radiotherapy for the treatment of different subgroups of patients with prostate cancer.

The European Medicines Agency had validated a marketing authorization application seeking the approval of the combination of encorafenib and binimetinib for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer.

Adjuvant treatment with pembrolizumab significantly improved overall survival vs placebo in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions, meeting a key secondary end point of the phase 3 KEYNOTE-564 trial.

The FDA has granted a fast track designation to SLS009 for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.

VAL-083 did not improve efficacy compared with standard-of-care approaches in patients with glioblastoma.

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

The FDA has approved toripalimab-tpzi (Loqtorzi) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.

The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.

The FDA has granted an orphan drug designation to TTX101 as a potential therapeutic option for patients with malignant glioma.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.