Takeda receives approval for fruzaqla in Japan for the treatment of unresectable advanced or recurrent colorectal cancer
- Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare to market FRUZAQLA (fruquintinib) for advanced or recurrent colorectal cancer.
- The approval is based on the FRESCO-2 trial, a global Phase 3 study that showed significant improvement in overall survival and progression-free survival.
- FRUZAQLA demonstrated a manageable safety profile, with adverse events leading to discontinuation being similar between the treatment and placebo groups.
- FRUZAQLA is already approved in the U.S., European Union, and several other countries, with plans to expand its availability further.
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Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR positive, HER2 low or negative breast cancer in TROPION-Breast01 phase 3 trial
- The TROPION-Breast01 phase 3 trial of datopotamab deruxtecan did not achieve statistical significance in the final overall survival (OS) analysis.
- The trial previously met the dual primary endpoint of progression-free survival (PFS) with significant improvement.
- The safety profile was consistent with previous analyses, showing lower rates of grade 3 or higher treatment-related adverse events compared to chemotherapy.
- Daiichi Sankyo and AstraZeneca will continue discussions with regulatory authorities and apply insights from these results to their clinical development program.
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Japan's Ministry of Health approves PADCEV with KEYTRUDA for first-line treatment of urothelial carcinoma
- Approval based on the EV-302 trial, which showed the combination nearly doubled median overall survival and significantly extended progression-free survival compared to platinum-containing chemotherapy.
- The approval follows a priority review designation from the Ministry of Health, Labour and Welfare due to the clinical usefulness and seriousness of the disease.
- The EV-302 trial enrolled 886 patients and demonstrated a median overall survival of 31.5 months with the combination therapy versus 16.1 months with chemotherapy.
- The combination therapy was previously approved by the European Commission and the U.S. FDA for similar indications.
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Innate Pharma announces FDA clearance of the IND for IPH4502, a Nectin-4 ADC to be developed in solid tumors
- Innate Pharma received FDA clearance for its IND application to initiate a Phase 1 clinical study of IPH4502.
- IPH4502 is a novel topoisomerase I inhibitor ADC targeting Nectin-4 in solid tumors.
- The Phase 1 study will include dose escalation and dose optimization parts, assessing safety, tolerability, and preliminary efficacy.
- The study will focus on advanced solid tumors expressing Nectin-4, including urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, and colorectal cancers.
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Silexion Therapeutics announces significant new data from Phase 2 trial of LODER in non-resectable pancreatic cancer
- Phase 2 trial of LODER in non-resectable locally advanced pancreatic cancer (LAPC) shows a 56% objective response rate (ORR).
- ORR increases to 67% in patients whose previously non-resectable tumors became resectable.
- LODER combined with standard-of-care chemotherapy previously showed a 9.3-month improvement in overall survival (OS).
- Silexion is developing SIL-204, targeting a broader range of KRAS mutations with improved stability and efficacy.
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bluebird bio initiates restructuring to optimize cost structure and enable cash flow break-even by 2025
- bluebird bio is implementing a restructuring to optimize its cost structure and achieve quarterly cash flow break-even by the second half of 2025.
- The restructuring includes a 20% reduction in cash operating expenses and a workforce reduction of approximately 25%.
- The company aims to scale to around 40 drug product deliveries per quarter and secure additional cash resources.
- Focus will be on the commercial launches of LYFGENIA, ZYNTEGLO, and SKYSONA, with an anticipated 40 patient starts in Q4 2024.
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Santhera announces acceptance by Swissmedic of marketing authorization application for AGAMREE (vamorolone) in Duchenne muscular dystrophy
- Swissmedic has accepted the marketing authorization application (MAA) for AGAMREE (vamorolone) for Duchenne muscular dystrophy (DMD).
- The application will be reviewed under Article 13 TPA, leveraging EU approval to streamline the process.
- Outcome expected in late H1-2026, with potential acceleration to early 2026.
- Swissmedic approval will complement existing approvals from the FDA, EMA, and MHRA, facilitating broader market access.
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UCB and Biogen announce positive topline results from phase 3 study of dapirolizumab pegol in systemic lupus erythematosus
- Phase 3 PHOENYCS GO study met the primary endpoint, showing clinical improvement in moderate-to-severe systemic lupus erythematosus (SLE).
- Clinical improvements were also observed in key secondary endpoints measuring disease activity and flares.
- The safety profile of dapirolizumab pegol was consistent with previous studies and expectations for SLE patients.
- UCB and Biogen will initiate a second Phase 3 trial, PHOENYCS FLY, in 2024, with long-term follow-up for PHOENYCS GO participants.
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AlgoTx announces last patient last visit in international phase II trial of ATX01 in chemotherapy-induced peripheral neuropathy
- AlgoTherapeutix (AlgoTx) has completed the Last Patient Last Visit (LPLV) in its Phase II trial of ATX01 for chemotherapy-induced peripheral neuropathy (CIPN).
- The trial, known as 'ACT', involved 276 patients across over 40 sites in the US, Belgium, Czechia, France, Italy, Poland, and Spain.
- ATX01 is a high-concentration, non-opioid topical formulation targeting specific nociceptive sodium channels to alleviate pain with minimal systemic exposure.
- Final data from the trial is expected in early 2025, with plans to expedite a Phase 3 trial.
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Repare Therapeutics announces new data underscoring need for additional treatment solutions for patients with metastatic gynecologic cancers
- Repare Therapeutics presented new data on alterations in FBXW7, PPP2R1A, and CCNE1 in metastatic ovarian and endometrial cancers.
- The data was shared at the AACR's 15th Annual Ovarian Cancer Research Symposium, highlighting chemotherapy resistance and lack of treatment options.
- Repare's Phase 1 MYTHIC trial is evaluating lunresertib and camonsertib in patients with these biomarkers, with data expected in Q4 2024.
- Patients with these biomarkers show significantly lower median overall survival rates in both ovarian and endometrial cancers.
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