Kristi Rosa

The FDA has granted a fast track designation to CUE-101 for use as a monotherapy and in combination with pembrolizumab in patients with human papillomavirus recurrent or metastatic head and neck squamous cell carcinoma.

The FDA has granted a fast track designation to sapanisertib as a potential therapeutic option in patients with unresected or metastatic squamous non–small cell lung cancer whose tumors harbor an NRF2 mutation and who have previously received platinum-based chemotherapy and immune checkpoint inhibition.

A biologics license application seeking the approval of a reformulation of denileukin diftitox for use as a potential therapeutic option in patients with persistent or recurrent cutaneous T-cell lymphoma has been submitted to the FDA.

The FDA has granted an accelerated approval to futibatinib (Lytgobi) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.

The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to select patients with RET fusion–positive locally advanced or metastatic non–small cell lung cancer, advanced or metastatic thyroid cancer, and advanced or metastatic medullary thyroid cancer who could be candidates to receive selpercatinib.

Giredestrant provided a numerical, but not statistically significant, improvement in progression-free survival over physician’s choice of endocrine therapy in patients with estrogen receptor–positive, HER2-negative, locally advanced or metastatic breast cancer, according to data from the phase 2 acelERA BC study.

The addition of pyrotinib to trastuzumab and docetaxel significantly improved progression-free survival vs trastuzumab/docetaxel alone in patients with HER2-positive metastatic breast cancer.

Pembrolizumab plus platinum/pemetrexed continued to demonstrate an overall survival and progression-free survival benefit vs platinum/pemetrexed alone in patients with previously untreated, metastatic squamous non–small cell lung cancer.

The FDA has granted a fast track designation to KIN-2787 for use as a potential therapeutic option in patients with BRAF class II or III alteration–positive and/or NRAS mutation–positive, metastatic or unresectable, stage IIB to IV malignant melanoma.

The FDA has granted accelerated approval to selpercatinib for adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion that have progressed on or after previous systemic treatment or who have no satisfactory alternative treatment options.

The FDA has granted a regular approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic non–small cell lung cancer harboring a RET gene fusion, as detected by an FDA-approved test.

Zanidatamab zovodotin was found to produce encouraging responses and to have a manageable toxicity profile when used as a monotherapy in heavily pretreated patients with HER2-positive solid cancers.

The FDA has approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors.

The China National Medical Products Administration has approved the supplemental new drug application seeking the approval of toripalimab plus pemetrexed and platinum as a frontline treatment in unresectable, locally advanced or metastatic, nonsquamous non–small cell lung cancer not harboring EGFR mutations or ALK fusions.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib for use in adult patients with marginal zone lymphoma who have received at least 1 prior anti–CD20-based therapy.

The FDA has granted a priority review to a supplemental new drug application seeking the approval of tucatinib for use in combination with trastuzumab in adult patients with HER2-positive colorectal cancer who have received at least 1 prior treatment regimen for unresectable or metastatic disease.

The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab for use in the frontline treatment of select patients with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.

The FDA has granted an orphan drug designation to the CDK7 inhibitor SY-5609 for use as a potential therapeutic option in patients with relapsed metastatic pancreatic cancer.

Maintenance treatment with niraparib produced a sustained and durable progression-free survival benefit in patients with primary advanced ovarian cancer who responded to first-line platinum-based chemotherapy, spanning biomarker subgroups.

Lasofoxifene plus abemaciclib produced promising efficacy when administered to pre- and postmenopausal patients with locally advanced or metastatic, estrogen receptor–positive, HER2-negative breast cancer who harbored an ESR1 mutation.

A supplemental new drug application and a Type II variation has been submitted to the FDA and the European Medicines Agency, respectively, seeking the approval of rucaparib as frontline maintenance treatment in women with advanced ovarian cancer irrespective of biomarker status who have responded to first-line platinum-based chemotherapy.

The addition of bevacizumab to trifluridine/tipiracil resulted in a statistically significant improvement in overall survival over trifluridine/tipiracil alone in patients with refractory metastatic colorectal cancer after 2 chemotherapy regimens.

The combination of lenvatinib and pembrolizumab was found to induce high response rates, including long-lasting remissions, and have acceptable safety in patients with metastasized anaplastic thyroid carcinoma and poorly differentiated thyroid carcinoma.

Tislelizumab continued to demonstrate an improved clinical benefit compared with docetaxel in both Asian and non-Asian patients with previously treated advanced non–small cell lung cancer.

Adjuvant osimertinib resulted in a 77% reduction in the risk of disease recurrence or death in patients with EGFR-mutated, stage II to IIIA non–small cell lung cancer, with a disease-free survival improvement observed irrespective of prior adjuvant chemotherapy or disease stage.

The combination of olaparib plus abiraterone acetate and prednisone or prednisolone demonstrated a continuing trend toward an overall survival benefit when used in the first-line treatment of patients with metastatic castration-resistant prostate cancer.

Amcenestrant did not significantly improve progression-free survival over physician’s choice of endocrine monotherapy in patients with endocrine-resistant, estrogen receptor–positive, HER2-negative advanced breast cancer, but it did provide a benefit that was numerically comparable, according to data from the phase 2 AMEERA-3 trial.

Pembrolizumab monotherapy and in combination with anlotinib demonstrated encouraging efficacy and safety when administered to patients with refractory or platinum-resistant recurrent high-grade serous ovarian cancer.

The European Commission has granted an orphan drug designation to nanatinostat and valganciclovir for use as a potential therapeutic option in patients with peripheral T-cell lymphoma.

The FDA has granted an orphan drug designation to AVA6000, a modified form of doxorubicin, for the treatment of patients with soft tissue sarcoma.