Search Results for "Chapter Members"

This ONS resource was produced for educational purposes only. Refer to the full talquetamab-tgvs (Talvey^™) package insert for all details.

Margetuximab-cmkb (Margenza^®) received U.S. Food and Drug Administration approval in December 2020 for previously treated adults with metastatic HER2-positive breast cancer after clinical trials demonstrated increased progression-free and overall survival. 

After an open-label, multicenter, single-arm trial demonstrated a 56% objective response rate, with 43% achieving complete responses, and an estimated 18.4-month median duration of response, the U.S. Food and Drug Administration granted glofitamab-gxbm (Columvi™) accelerated approval in June 2023. 

In clinical trials, pirobrutinib (Jaypirca^™) was effective in restoring BTK inhibition in patients that experienced progression after previously receiving a covalent BTK inhibitor. Pirobrutinib became the first-available noncovalent (reversible) BTK inhibitor in January 2023 when the U.S. Food and Drug Administration granted it accelerated approval.

A gene found on many germline cancer testing panels, RecQ like helicase 4 (RECQL4) is located on chromosome 8. Although it was first described in 1998, its associated cancer risks and implications for treatment are still not well understood.

In a clinical trial of 65 patients with metastatic or recurrent Merkel cell carcinoma who had not previously received systemic therapy for advanced disease, treatment with retifanlimab-dlwr (Zynyz^™) achieved a 52% overall response rate and 18% complete response rate, leading the U.S. Food and Drug Administration to grant it accelerated approval in March 2023.