Kristi Rosa

The combination of ribociclib and endocrine therapy (ET) significantly reduced the risk of disease recurrence vs standard adjuvant ET in patients with hormone receptor–positive/HER2-negative early breast cancer at risk of recurrence.

The combination of durvalumab, tremelimumab, and hypofractionated radiotherapy demonstrated early tolerability in patients with gynecologic malignancies and elicited objective responses in those with PD-L1–high tumors.

The FDA has approved retifanlimab-dlwr (Zynyz) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.

A new drug application seeking the approval of Lumisight, an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection, has been submitted to the FDA.

When the fully human IgG4 monoclonal antibody SRK-181 was given as a monotherapy or in combination with anti–PD-1 or PD-L1 agents in patients with locally advanced or metastatic solid tumors, it was found to be generally well tolerated and to demonstrate early indications of efficacy.

The FDA has granted an orphan drug designation to EP0042 for use as a potential therapeutic option in patients with acute myeloid leukemia with acquired resistance to FLT3 inhibitors.

Precision medicine has arrived in all stages of prostate cancer care and recommendations for optimal testing and how best to leverage the results to inform clinical decisions continue to rapidly evolve.

Durvalumab plus neoadjuvant chemotherapy followed by surgery and adjuvant single-agent durvalumab significantly improved event-free survival vs neoadjuvant chemotherapy and surgery alone in patients with resectable stage IIA-IIIB non–small cell lung cancer.

The combination of cabozantinib and atezolizumab did not significantly improve progression-free survival over cabozantinib alone in patients with locally advanced or metastatic clear cell or non–clear cell renal cell carcinoma who progressed during or following checkpoint inhibition, missing the primary end point of the phase 3 CONTACT-03 trial.

Lasofoxifene improved vaginal/vulvar symptoms compared with fulvestrant in premenopausal patients with locally advanced or metastatic estrogen receptor–positive/HER2-negative breast cancer harboring an ESR1 mutation.

The FDA has approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv (Udenyca), which is a biosimilar of pegfilgrastim that is given the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.

The FDA has granted an orphan drug designation to Temferon for use as a potential therapeutic option in patients with glioblastoma multiforme.

A biologics license application seeking the approval of cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma has been accepted for filing by the FDA.

The antibody-drug conjugate ARX788 was found to significantly improve progression-free survival compared with an active control in patients with HER2-positive locally advanced or metastatic breast cancer.

The FDA has provided PDS Biotechnology Corporation with guidance on the required contents of a design for a potential registrational trial examining PDS0101 in combination with PDS0301 and an FDA-approved immune checkpoint inhibitor in patients with recurrent or metastatic human papillomavirus–positive, ICI-refractory head and neck cancer.

The National Medical Products Administration of China has granted approval to tislelizumab in combination with fluoropyrimidine and platinum chemotherapy in the frontline treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with a high PD-L1 expression.

The National Medical Products Administration of China has approved the use of single-agent fam-trastuzumab deruxtecan-nxki in adult patients with unresectable or metastatic HER2-positive breast cancer who previously received 1 or more anti–HER2-based regimens.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab-rwlc in combination with platinum-based chemotherapy as frontline treatment for adult patients with advanced non–small cell lung cancer with PD-L1 expression of 1% or higher.

The combination of the targeted immunotherapy Bria-IMT and retifanlimab demonstrated signs of clinical benefit and was found to be well tolerated in patients with advanced metastatic breast cancer.

The European Commission has approved the tablet formulation of acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia.

Treatment with cabozantinib elicited responses in patients with locally advanced or metastatic renal cell carcinoma with a clear-cell component who had progressed after first-line treatment with checkpoint inhibitor–based combination therapy.

Orca-Q when using myeloablative conditioning with only tacrolimus monotherapy in the haploidentical stem cell transplant setting had acceptable safety and resulted in encouraging outcomes for patients with high-risk hematologic malignancies.

The addition of pembrolizumab to chemotherapy resulted in a significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate vs chemotherapy alone when used as first-line treatment in patients with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma.

The fully-human scFv CD19-targeted CAR T-cell therapy JCAR021 elicited durable responses but with a high rate of neurotoxicity when administered at a dose of 7 x 106 cells/kg in patients with relapsed or refractory large B-cell lymphoma, according to data from a phase 1/2 trial.

The combination of maveropepimut-S, pembrolizumab, and intermittent low-dose cyclophosphamide elicited responses in patients with relapsed or refractory diffuse large B-cell lymphoma, according to preliminary findings from the phase 2b VITALIZE trial.

The FDA has granted a regular approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient, recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

Neoadjuvant pembrolizumab was found to have high clinical activity and an acceptable safety profile in patients with localized microsatellite instability–high/deficient mismatch repair solid tumors.

The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a BTK inhibitor.

The addition of nab-paclitaxel to gemcitabine and cisplatin did not result in a statistically significant improvement in overall survival over gemcitabine/cisplatin alone in patients with newly diagnosed, advanced biliary tract cancers.