Positive Opinion from CHMP For Toripalimab Announced

“As a leading innovative pharmaceutical company in China,” Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “Junshi Biosciences is dedicated to addressing the clinical needs of local patients while offering novel therapies that provide survival benefits to patients globally. Currently, patients with NPC and ESCC in Europe receive limited clinical benefits from existing treatments. Toripalimab has the potential to improve their treatment options. The positive opinion from the CHMP brings us one step closer to this goal. We will continue communicating with local regulatory authorities so that our innovative therapy can benefit more European patients as soon as possible.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is