FDA approves perioperative treatment with Opdivo for resectable NSCLC
- The FDA has approved Opdivo (nivolumab) for perioperative treatment in resectable non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements.
- Approval is based on the CheckMate-77T trial, which showed improved event-free survival (EFS) and pathologic complete response (pCR) rates with Opdivo.
- Opdivo demonstrated a 42% reduction in the risk of disease recurrence, progression, or death compared to chemotherapy and placebo.
- The recommended regimen includes neoadjuvant Opdivo with chemotherapy followed by adjuvant Opdivo post-surgery.
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Calquence granted priority review in the US for untreated mantle cell lymphoma
- AstraZeneca's Calquence (acalabrutinib) received Priority Review from the FDA for treating untreated mantle cell lymphoma (MCL).
- The ECHO Phase III trial showed Calquence plus chemoimmunotherapy reduced disease progression risk by 27% compared to standard care.
- The FDA's decision is expected in the first quarter of 2025, with the review conducted under Project Orbis for global access.
- Calquence is a BTK inhibitor, already approved for other indications, and is being evaluated for multiple B-cell blood cancers.
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FDA approves Exact Sciences’ Cologuard Plus test for colorectal cancer screening
- The FDA has approved the Cologuard Plus test for adults aged 45 and older at average risk for colorectal cancer.
- Approval was based on the pivotal BLUE-C study, which showed 95% cancer sensitivity and 43% sensitivity for advanced precancerous lesions.
- The test outperformed the fecal immunochemical test (FIT) in sensitivity for colorectal cancer and advanced precancerous lesions.
- Cologuard Plus is expected to launch in 2025, with anticipated Medicare coverage and inclusion in U.S. Preventive Services Taskforce guidelines.
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Oncolytics Biotech announces progress in breast and pancreatic cancer treatments
- BRACELET-1 trial results in HR+/HER2- breast cancer show strong efficacy, paving the way for an accelerated approval path.
- A Phase 2 study for pelareorep + paclitaxel in HR+/HER2- metastatic breast cancer is planned for early 2025, targeting 180 patients.
- Collaboration with GCAR and PanCAN to advance pelareorep in pancreatic cancer through the GOBLET study.
- Key milestones include initiating a registrational study in breast cancer and updates on pancreatic cancer studies in 2025.
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Summit Therapeutics completes enrollment in phase III HARMONi trial for NSCLC
- Summit Therapeutics has completed enrollment for the HARMONi Phase III trial, evaluating ivonescimab with chemotherapy in EGFR-mutated NSCLC patients.
- The trial involves patients from North America, Europe, and China, focusing on those who progressed after 3rd generation EGFR TKI treatment.
- The FDA granted Fast Track designation to ivonescimab, facilitating its development and review for unmet medical needs.
- HARMONi trial aims to assess progression-free survival and overall survival as primary endpoints.
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ABL Bio announces clinical collaboration to evaluate ABL103 in combination with Keytruda in patients with solid tumors
- ABL Bio has entered a clinical trial collaboration with MSD to evaluate ABL103 with Keytruda in a Phase 1b/2 trial.
- The trial will assess the safety and efficacy of ABL103, a bispecific antibody targeting B7-H4 and 4-1BB.
- Keytruda will be supplied by MSD for the study, focusing on advanced or metastatic solid tumors.
- The dose escalation part of the Phase 1 trial for ABL103 is currently ongoing in South Korea.
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Aldeyra resubmits NDA for reproxalap in dry eye disease
- Aldeyra Therapeutics has resubmitted a New Drug Application (NDA) to the FDA for reproxalap, targeting dry eye disease.
- The resubmission includes positive results from a Phase 3 trial showing reproxalap's effectiveness in reducing ocular discomfort.
- Reproxalap demonstrated acute and chronic activity in reducing dry eye symptoms and ocular redness.
- The FDA is expected to review the resubmission within 6 months, following the Prescription Drug User Fee Act guidelines.
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OS Therapies completes last patient visit in OST-HER2 osteosarcoma phase 2b trial
- OS Therapies announced the completion of the last patient visit in the AOST-2121 Phase 2b trial for OST-HER2 in osteosarcoma.
- The trial involved 41 patients across 21 sites in the U.S., focusing on event-free survival and overall survival as primary endpoints.
- The company plans to request a Type C Meeting with the FDA for protocol adjustments before data analysis.
- Topline data readout is expected in the fourth quarter of 2024.
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Health Canada approves label expansion for Telix’s Illuccix to include patient selection for PSMA-targeted therapy
- Health Canada has approved the use of Illuccix for selecting patients with progressive metastatic castration-resistant prostate cancer for PSMA-targeted radionuclide therapy.
- Illuccix is now approved in Canada for use with gallium-based PSMA-PET imaging to identify suitable candidates for PSMA-targeted therapy.
- The approval expands Illuccix's clinical utility, which was previously approved for staging and re-staging prostate cancer and localizing tumor tissue in recurrent cases.
- Illuccix is distributed across Canada through Isologic Innovative Radiopharmaceuticals, reaching 265 hospitals and clinics.
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IDEAYA Biosciences presents IDE397 phase 1 results in MTAP-deletion cancers
- IDEAYA Biosciences announced a late-breaking oral presentation of IDE397 Phase 1 expansion results.
- IDE397 is a first-in-class, oral MAT2A inhibitor targeting MTAP-deletion in lung and urothelial cancers.
- The presentation took place at the EORTC-NCI-AACR Symposium in Barcelona, Spain.
- Additional poster presentations highlighted preclinical data for MAT2A and PARG programs.
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