Chris Ryan

First-line niraparib maintenance was not associated with worsened health-related quality of life outcomes vs placebo in advanced ovarian cancer.

The FDA has accepted a new drug application for ensartinib in metastatic ALK-positive non–small cell lung cancer.

The FDA has granted orphan drug designation to LYT-200 for the treatment of acute myeloid leukemia.

TNO155 plus spartalizumab or ribociclib was well tolerated and demonstrated disease control in patients with advanced solid tumors.

The FDA has lifted a partial clinical hold on a phase 1 trial evaluating NX-2127 in relapsed/refractory B-cell malignancies

The addition of UV1 to nivolumab/ipilimumab failed to improve PFS in the frontline treatment of unresectable or metastatic melanoma.

The FDA granted accelerated approval to zanubrutinib in combination with obinutuzumab for select patients with relapsed/refractory follicular lymphoma.

ABSK061 was well tolerated and elicited responses in patients with advanced solid tumors harboring FGFR2/3 alterations.

Avutometinib alone or in combination with defactinib has received an orphan drug from the FDA for recurrent low-grade serous ovarian cancer.

Iopofosine plus EBRT elicited a 64% CR rate and was well tolerated in patients with locoregionally recurrent/metastatic head and neck cancer.

The FDA has approved the biosimilars denosumab-bddz (Wyost) and denosumab-bddz (Jubbonti) for use in all indications of the reference medicines denosumab (Xgeva) and denosumab (Prolia).

The partial clinical hold placed on the phase 2 IOV-LUN-202 trial of LN-145 in non–small cell lung cancer has been lifted by the FDA.

China’s NMPA has approved zevor-cel for the treatment of adult patients with relapsed/refractory multiple myeloma after at least 3 lines of therapy.

HIPEC was not associated with additional complications or worse survival in patients with FIGO stage IV ovarian cancer vs those with stage III disease.

Most oncology drugs approved by the EMA recover research and development costs within a few years, even if the drug is providing little added benefit.

The FDA has granted fast track designation to IDP-023 for the treatment of patients with non-Hodgkin lymphoma and multiple myeloma

The FDA granted fast track designation to 9MW2821 for potential use in advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Bezuclastinib plus BSC improved mast cell burden and total symptom score vs placebo plus BSC in adult patients with nonadvanced systemic mastocytosis.

The FDA has granted breakthrough therapy designation to NVL-520 for pretreated, metastatic ROS1-positive non–small cell lung cancer.

The FDA has granted priority review to the sBLA of epcoritamab for relapsed/refractory follicular lymphoma.

Howard I. Scher, MD, took a passion for improving cancer care and patient outcomes in prostate cancer and turned it into an extraordinary and explosive field of clinical research.

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.