Ono Pharma's Opdivo Approved with Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma
Thursday, October 10, 2024
Ono Pharmaceutical has received approval from the Taiwan Food and Drug Administration (TFDA) for the expanded use of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine.
Opdivo, an immune checkpoint inhibitor, enhances the body’s immune system by blocking PD-1, aiding the body in fighting cancer. Approved in over 65 countries, including Japan, the US, and the EU, Opdivo has become an essential option for treating various cancers.
Since its initial approval in Japan in 2014 for melanoma, it has gained additional approvals for conditions such as lung cancer, renal cell carcinoma, and Hodgkin lymphoma, among others.
Urothelial carcinoma accounts for 90% of bladder cancer cases, with high rates of recurrence and progression. For patients with metastatic disease, the prognosis remains poor, and median survival with treatment typically ranges between 12 and 14 months.
This approval, granted on October 9, applies to the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.
The decision was based on data from the Phase 3 CheckMate -901 study, which evaluated Opdivo alongside cisplatin and gemcitabine, followed by Opdivo monotherapy, against the use of cisplatin and gemcitabine alone.
The results showed significant improvements in overall survival (OS) and progression-free survival (PFS), as reviewed by a Blinded Independent Central Review (BICR). The safety profile was consistent with known risks, and no new safety concerns were noted.
Opdivo had already been approved in Taiwan for urothelial carcinoma in two other cases: for patients who failed prior platinum-containing therapies (October 2017) and as an adjuvant treatment for those at high risk of recurrence post-surgery (April 2022).
The CheckMate -901 trial continues to explore other combinations, including Opdivo with Yervoy® (ipilimumab) in this patient group.
Ono has also filed a supplemental application for its use in hepatocellular carcinoma.
Source: ono-pharma.com
