相关临床试验
92
87 进行中
药物批准
6
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
87
94.6%
已完成
2
2.2%
招募中
2
2.2%
撤回
1
1.1%
- The Delhi High Court overturned the Patent Office's rejection of Array BioPharma's patent application for a pharmaceutical combination targeting colorectal cancer and other proliferative diseases. - The court ruled that the Deputy Controller's findings on lack of inventive step and non-patentability under Sections 3(d) and 3(i) of the Patents Act could not be sustained. - The court clarified that Section 3(i) bars only processes for treatment, not pharmaceutical combinations or products, and that none of the cited prior art disclosed the specific B-Raf/EGFR/PI3K-alpha inhibitor combination. - The matter has been remanded for fresh consideration within six months with an opportunity for the applicant to be heard.
- Ono Pharmaceutical received supplemental approval in Japan and additional approval in South Korea for BRAFTOVI (encorafenib) combination therapy as first-line treatment for unresectable, advanced or recurrent colorectal cancer with BRAF mutation. - The Phase 3 BREAKWATER study demonstrated statistically significant improvements in objective response rate (60.9% vs 40.0%, p = 0.0008) and progression-free survival (12.8 vs 7.1 months, p < 0.0001) compared to chemotherapy alone. - The combination therapy addresses a significant unmet medical need, as BRAF-mutant colorectal cancer patients represent 4.5-6.7% of cases in Japan and have poorer prognosis than those without the mutation. - This approval provides the first targeted treatment option for first-line therapy in BRAF-mutant colorectal cancer, expanding beyond previously approved second-line indications.
