Kristi Rosa

Treatment with FOLFIRINOX resulted in a significantly longer progression-free survival than that achieved with gemcitabine in patients with locally advanced pancreatic carcinoma, meeting the primary end point of the phase 3 NEOPAN trial.

The FDA has granted a fast track designation to MT-101 for use as a potential therapeutic option in patients with relapsed or refractory, CD5-positive peripheral T-cell lymphoma.

The FDA has granted a fast track designation to 177Lu-edotreotide for use as a potential therapeutic option in patients with gastroenteropancreatic neuroendocrine tumors.

A regimen comprised of radiation and intermittent hormone therapy (HT) resulted in an improvement in progression-free survival in patients with oligometastatic prostate cancer, according to data from the phase 2 EXTEND trial.

The FDA has granted accelerated approval to teclistamab-cqyv (Tecvayli) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The China National Medical Products Administration has granted a breakthrough therapy designation to ivonescimab for use in combination with chemotherapy in patients with EGFR-mutated advanced non–small cell lung cancer in whom prior treatment with an EGFR TKI has failed.

Adjuvant treatment with nivolumab resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival over placebo in patients with completely resected stage IIB or IIC melanoma.

The addition of palbociclib to adjuvant endocrine therapy (ET) failed to improve invasive disease-free survival over ET alone in patients with estrogen receptor–positive, HER2-negative early breast cancer.

The therapeutic DNA vaccine, GX-188E, in combination with pembrolizumab produced encouraging responses in patients with human papillomavirus 16- or 18-positive, recurrent or metastatic cervical cancer who did not respond to standard-of-care treatment.

A combination regimen comprised of sotorasib and BBP-398 has been awarded a fast track designation from the FDA for use as a potential therapeutic option in adult patients with previously treated, KRAS G12C–mutated, metastatic non–small cell lung cancer.

Patients with non–clear cell renal cell carcinoma and sarcomatoid differentiation experience inferior outcomes to standard systemic therapy compared with those with clear cell disease.

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.