Kristi Rosa

The FDA has approved tremelimumab-actl (Imjudo) plus durvalumab (Imfinzi) and platinum-based chemotherapy for adult patients with metastatic non–small cell lung cancer without sensitizing EGFR mutation or ALK aberrations.

The FDA has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma.

Milademetan monotherapy demonstrated preliminary antitumor activity in patients with MDM2-amplified and p53 wild-type advanced solid tumors.

The NALIRIFOX regimen significantly improved overall survival over nab-paclitaxel plus gemcitabine in previously untreated patients with metastatic pancreatic ductal adenocarcinoma, meeting the primary end point of the phase 3 NAPOLI 3 trial.

The FDA has approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy in adult patients with advanced non–small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.

A doublet regimen comprised of pembrolizumab and cabozantinib elicited encouraging responses in patients with recurrent metastatic head and neck squamous cell carcinoma, meeting the primary end point of a phase 2 trial.

The liposome formulation of irinotecan, HR070803, in combination with 5-fluororacil and leucovorin provided a statistically significant overall survival benefit to patients with gemcitabine-refractory locally advanced or metastatic pancreatic cancer.

The FDA has approved leuprolide acetate injection for use in the palliative treatment of patients with advanced prostate cancer.

The FDA has approved cobimetinib (Cotellic) for the treatment of adult patients with histiocytic neoplasms.

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.