Plus   Neg

Junshi Biosciences : FDA Grants Toripalimab Fast Track Designation For Mucosal Melanoma

Junshi Biosciences said that U.S. Food and Drug Administration has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma.

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma.

The trial plans to enroll 220 patients who will be randomized at 1:1 ratio into two study arms. The primary endpoint of the Combination Clinical Trial is progression-free survival (PFS). The secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.

Mucosal melanoma is a subtype of melanoma with mucosal origin. Compared with cutaneous melanoma, mucosal melanoma is less responsive to traditional chemotherapy and immunotherapy, and thus remains an unmet medical need.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Walmart Inc. has launched a nationwide drive to boost COVID-19 vaccination rates by reaching out to more residents in vulnerable communities. The retail giant will organize a series of community events at 43 locations in 18 states to administer the COVID-19 vaccine. Walmart said it plans to continue these new events over the next several weeks as vaccine allocations allow. Pfizer Inc. (PFE) and OPKO Health Inc. (OPK) announced Friday that the European Medicines Agency or EMA has validated for review the Marketing Authorization Application for somatrogon. Pfizer expects a decision from the European Commission in 2022. The company said somatrogon is a long-acting recombinant... German telecom giant Deutsche Telekom AG reported Friday strong growth in fourth-quarter profit mainly driven by T-Mobile US results following the takeover of the competitor Sprint. Looking ahead for fiscal 2021, the company projects higher adjusted EBITDA AL, a key earnings metric.
Follow RTT