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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more