October 4, 2024 - 🧬 [nGram] Today’s Neurology Scoop: CALQUENCE® Priority Review, Opdivo® Approval, Reproxalap Resubmission

1. 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 under Project Orbis for global access.
   • Calquence is a Bruton tyrosine kinase inhibitor, already approved for other indications like chronic lymphocytic leukemia.
   Read more
   
   

2. FDA approves perioperative treatment with Opdivo for resectable NSCLC

   • The FDA has approved Opdivo (nivolumab) for perioperative treatment in adult patients with resectable non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements.
   • The approval is based on the CheckMate-77T trial, which showed improved event-free survival (EFS) and a higher pathologic complete response (pCR) rate with Opdivo plus chemotherapy compared to chemotherapy alone.
   • Patients in the Opdivo arm had a 42% reduced risk of disease recurrence, progression, or death, with 70% achieving 18-month EFS.
   • Opdivo is now the only PD-1 inhibitor approved for both neoadjuvant and perioperative regimens in resectable NSCLC.
   Read more
   
   

3. Aldeyra Therapeutics resubmits reproxalap new drug application for 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 is a first-in-class small-molecule modulator of RASP, studied in over 2,500 patients with no major safety concerns.
   • The FDA's review of the resubmission is expected to be completed within 6 months.
   Read more
   
   

4. 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 is multi-regional, involving sites in North America, Europe, and China, targeting patients who progressed after EGFR-TKI therapy.
   • The FDA has granted Fast Track designation to ivonescimab, facilitating its development and review process.
   • HARMONi trial aims to assess progression-free survival and overall survival as primary endpoints.
   Read more