Clinical Trials
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- The EMA's CHMP has adopted a positive opinion recommending marketing authorisation for Sepalna (senaparib) as maintenance treatment of advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. - The opinion rests on the pivotal Phase III FLAMES trial, where senaparib cut the risk of progression or death by 57% versus placebo, with a hazard ratio of 0.43. - Median progression-free survival was not reached with senaparib versus 13.6 months with placebo at the prespecified interim analysis, with benefit seen irrespective of BRCA mutation status. - IMPACT Therapeutics licensed exclusive rights across 66 countries to Pharmanovia in July 2026, and the European Commission will now issue the final decision on EU-wide marketing.
- IMPACT Therapeutics has signed an exclusive licensing agreement with Pharmanovia for senaparib across 66 countries including Europe, MENA, Australia, and New Zealand. - The deal includes up to €423.5 million in total consideration, comprising upfront, regulatory milestone, and commercial milestone payments, plus tiered royalties up to the mid-twenties percent. - Senaparib's European Marketing Authorisation Application was accepted by the EMA in August 2025, with approval expected in the second half of 2026. - The agreement marks IMPACT's first expansion of its validated PARP1/2 inhibitor beyond China, where senaparib received NMPA approval in January 2025.
- Pharmanovia has launched Korjuny (catumaxomab) in Germany, marking the first and only approved pharmacological treatment for malignant ascites, a debilitating complication of advanced-stage cancer. - The trifunctional antibody targets EpCAM-positive carcinomas and engages T-cells to destroy cancer cells while offering prolonged puncture-free survival for patients ineligible for systemic anticancer therapy. - Catumaxomab received marketing authorization from the European Medicines Agency's CHMP on February 10, 2025, addressing a significant unmet medical need in oncology care. - The launch represents a major milestone for Pharmanovia's specialty oncology portfolio and its partnership with Lindis Biotech to expand patient access to innovative cancer treatments.
- Catumaxomab, a first-in-class trifunctional antibody, has been granted European Commission marketing authorization for malignant ascites. - The approval makes catumaxomab the only approved drug therapy for malignant ascites, a complication of advanced-stage cancers. - Pharmanovia has secured exclusive rights from Lindis Biotech to commercialize and launch catumaxomab across Europe. - Catumaxomab targets EpCAM-positive carcinomas, offering a novel approach by engaging T-cells to destroy cancer cells.
- Lindis Biotech has partnered with Pharmanovia to relaunch Catumaxomab, a bifunctional antibody therapy, following a positive review from the EMA's Committee for Medicinal Products for Human Use. - Catumaxomab is poised to become the first approved treatment for malignant ascites, a condition frequently associated with advanced cancers such as ovarian and pancreatic cancer. - The drug targets EpCAM-positive carcinomas, aiming to enhance patient quality of life by decreasing reliance on paracentesis and potentially prolonging survival. - Pharmanovia will lead the marketing efforts for Catumaxomab, with both companies expressing optimism about alleviating the burden of malignant ascites on patients.
- Pharmanovia has secured exclusive rights to commercialize catumaxomab, a trifunctional bispecific monoclonal antibody, for treating malignant ascites. - Catumaxomab targets EpCAM-positive carcinomas and enhances the patient's immune system to kill tumor cells, offering a novel approach. - The EMA's CHMP issued a positive opinion on catumaxomab in October 2024, potentially making it the only approved drug for malignant ascites. - Pharmanovia aims to reintroduce catumaxomab to the market, pending regulatory approval, to address the unmet needs in cancer supportive care.
