Chris Ryan

The FDA granted priority review to the sBLA for isatuximab plus bortezomib/lenalidomide/dexamethasone for newly diagnosed, transplant-ineligible myeloma.

Patients under the age of 40 who received HPV vaccines were associated with lower rates of HPV-related cancer vs unvaccinated patients.

Tumor-infiltrating B lymphocytes were associated with worse outcomes in patients with metastatic ccRCC treated with axitinib plus anti–PD-1 therapy.

The FDA has granted orphan drug designation to azeliragon as a potential therapeutic option for patients with pancreatic cancer.

The FDA has updated the PDUFA target action date for the BLA for subcutaneous nivolumab in advanced or metastatic solid tumors.

The FDA has withdrawn the approval of infigratinib for previously treated, FGFR2-positive, advanced cholangiocarcinoma.

Adding denosumab to neoadjuvant nab-paclitaxel did not improve 5-year invasive disease-free survival rates in patients with early-stage breast cancer.

The FDA will hold an end-of-phase 2 meeting to discuss botensilimab plus balstilimab for the treatment of patients with relapsed/refractory metastatic colorectal cancer.

The FDA has granted accelerated approval to lisocabtagene maraleucel for the treatment of select adult patients with relapsed or refractory follicular lymphoma.

First-line atezolizumab plus sacituzumab govitecan led to responses in PD-L1–positive locally advanced or metastatic triple-negative breast cancer.

Relatlimab plus nivolumab and chemotherapy did not improve responses in untreated advanced gastric or GEJ cancer with a LAG-3 expression of at least 1%.

Nivolumab plus concurrent chemoradiotherapy, followed by nivolumab plus ipilimumab, did not improve PFS in unresectable stage III NSCLC.

A retrospective analysis showed that metastasectomy plus radical nephrectomy could improve survival in patients with metastatic non–clear cell RCC.

NICE recommends Oncotype DX to guide chemotherapy decisions in early-stage, HR-positive, HER2-negative breast cancer involving up to 3 positive nodes.

First-line treatment with the combination of Versamune HPV and pembrolizumab met a best overall response end point in recurrent/metastatic HNSCC.

The FDA has granted a breakthrough device designation to Teal Wand, an at-home screening test for cervical cancer.

The FDA has granted orphan drug designation to 9MW2821 as a potential treatment for patients with esophageal cancer.

Setanaxib plus pembrolizumab improved progression-free survival and overall survival in recurrent or metastatic head and neck squamous cell carcinoma.

The FDA has approved ColoSense for use as a screening test in adults 45 years of age or older who are at average risk of developing colorectal cancer.

SLS009 plus venetoclax and azacitidine elicited responses in patients with relapsed/refractory AML, particularly in those harboring ASXL1 mutations.

Treatment with EVT801 was well tolerated and led to a stable disease rate of 46% in patients with advanced ovarian cancer.

Glecirasib elicited responses and demonstrated a manageable safety profile in patients with pretreated advanced NSCLC harboring KRAS G12C mutations.

The FDA granted full approval to tisotumab vedotin for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Trastuzumab deruxtecan improved PFS vs chemotherapy in HR-positive, HER2-low metastatic breast cancer after 1 or more lines of endocrine therapy.

The EMA’s CHMP recommended capivasertib/fulvestrant for ER-positive, HER2-negative advanced breast cancer harboring PIK3CA, AKT1, or PTEN alterations.

A new drug application seeking the approval of toripalimab for the treatment of patients with nasopharyngeal carcinoma is under review in Hong Kong.

The FDA granted accelerated approval to tovorafenib for pediatric patients relapsed/refractory low-grade glioma with a BRAF fusion/rearrangement or a BRAF V600 mutation.

The FDA has approved lutetium Lu 177 dotatate for pediatric patients 12 years of age and older with SSTR–positive GEP-NETs.

Health Canada has approved subcutaneous atezolizumab for use in patients with lung cancer, breast cancer, and hepatocellular carcinoma.

VCN-01 was safe and elicited signs of antitumor activity in patients with intraocular retinoblastoma that was refractory to chemotherapy or radiotherapy.