Chris Ryan

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.

Health Canada has approved relugolix for the treatment of men with advanced prostate cancer.

The European Commission has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with advanced non–small cell lung cancer whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Treatment with platinum-based chemotherapy prior to the administration of chemoradiation led to statistically significant improvements in progression-free survival and overall survival compared with chemoradiation alone in patients with locally advanced cervical cancer.

Second-line treatment with sacituzumab govitecan-hziy led to responses in patients with extensive-stage small cell lung cancer, according to results from the phase 2 TROPiCS-03 trial.

The United Kingdom’s National Institute for Health and Care Excellence has issued a final draft guidance recommending the approval of zanubrutinib for the treatment of adult patients with untreated, high-risk chronic lymphocytic leukemia harboring a 17p deletion or TP53 mutation.

The European Commission has approved brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine for the treatment of adult patients with previously untreated, CD30-positive, stage III Hodgkin lymphoma.

Treatment with subcutaneous nivolumab co-formulated with recombinant human hyaluronidase demonstrated noninferior pharmacokinetics vs intravenous nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy.

The novel mRNA biomarkers in the noninvasive ColoAlert® screening test displayed sensitivity and specificity for detecting colorectal cancer and advanced adenomas that could be precursors to CRC.

The addition of SLS009 to the combination of venetoclax and azacitidine produced anti-leukemic effects and was safe in patients with relapsed/refractory acute myeloid leukemia who did not respond or stopped responding to venetoclax-based therapies.

Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.

The FDA has granted priority review to the supplemental new drug application seeking the approval of osimertinib in combination with chemotherapy for the treatment of patients with EGFR-mutated locally advanced or metastatic non–small cell lung cancer.

The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of adult and pediatric patients 12 years of age and older with completely resected stage IIB or IIC melanoma.

The FDA has approved FoundationOne® CDx and FoundationOne Liquid CDx for use as companion diagnostics to identify patients with metastatic non–small cell lung cancer harboring BRAF V600E mutations who may benefit from treatment with the combination of encorafenib plus binimetinib.

First-line treatment with the universal cancer vaccine UV1 in combination with pembrolizumab sustained overall survival in patients with advanced unresectable or metastatic malignant melanoma, according to updated data from cohort 1 of the phase 1 UV1-103 trial.

Treatment with intratumoral large surface area microparticle paclitaxel led to disease control and was well tolerated in patients with locally advanced pancreatic cancer.

The addition of TPST-1120 to the combination of atezolizumab and bevacizumab led to improved responses vs atezolizumab plus bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.

The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.

Treatment with the combination of the investigational oral innate immune activator BXCL701 and pembrolizumab led to a median overall survival of 13.6 months in patients with small cell neuroendocrine carcinoma metastatic castration-resistant prostate cancer.

The duration of treatment with the combination of venetoclax and ibrutinib could be guided by both toxicities and minimal residual disease kinetics in previously untreated patients with intermediate-risk chronic lymphocytic leukemia, according to interim results from the phase 2 ERADIC trial.

The FDA has placed a partial clinical hold on investigational new drug application for lacutamab, leading to a pause in new patient enrollment for the phase 2 TELLOMAK trial and a phase 1b trial, which are evaluating the agent in patients with advanced cutaneous T-cell lymphoma and peripheral T-cell lymphoma, respectively.

In a 14-to-6 vote, the FDA’s Oncologic Drugs Advisory Committee voted sufficient evidence has been provided to demonstrate the event-free survival benefit of eflornithine to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma.

In a 10-to-2 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the data for progression-free survival per blinded independent central review from the phase 3 CodeBreaK 200 trial evaluating sotorasib vs docetaxel for the treatment of patients with pretreated, locally advanced or metastatic KRAS G12C–mutated non–small cell lung cancer cannot be reliably interpreted.

First-line treatment with the combination of motixafortide, cemiplimab-rwlc, gemcitabine, and nab-paclitaxel elicited responses in patients with metastatic pancreatic adenocarcinoma, according to initial data from the pilot portion of a phase 2 trial.

The FDA has approved the CRCdx® RAS Mutation Detection Kit as a companion diagnostic for panitumumab in the treatment of patients with metastatic colorectal cancer, according to an announcement from EntroGen.