Candel Therapeutics Receives U.S. FDA Fast Track Designation for CAN-2409 to Treat Stage III/IV NSCLC Patients

Candel Therapeutics receives FDA’s fast track designation for CAN-2409, a viral immunotherapy developed to improve survival in combination with valacyclovir and pembrolizumab to treat stage III/IV non-small cell lung cancer patients resistant to first-line PD-(L)1 inhibitor therapy. Fast track designation helps expedite the review process and may allow for accelerated approval and priority review.

Publish Date: 17-04-2023 Source: Candel Therapeutics, Inc.

Non–small cell lung cancer (NSCLC) is the most common form of lung cancer. Early-stage NSCLC accounts for approximately 18% of the cases. Most patients are treated with curative intent and often require multimodality therapy. The 5-year overall survival (OS) ranges from 50% for stage IA disease to 15% for stage IIIA NSCLC. Several clinical trials have demonstrated improved survival with postoperative chemotherapy in selected patients who undergo complete surgical resection. Available evidence supports the use of adjuvant chemotherapy for stage II and stages IIIA but not for stage IA NSCLC. The standard of care for patients with stage I and II and IIIA, non-small-cell lung cancer (NSCLC), is surgical resection. Following resection, patients may be offered adjuvant systemic therapy.

HER2 mutations and HER2 amplifications have been reported in approximately 2% to 3% and 2% to 5% of lung adenocarcinomas, respectively.

However, the current Non–Small Cell Lung Cancer (NSCLC) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Datopotamab Deruxtecan, Zimberelimab, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the NSCLC treatment. The key companies in the advanced development stage are Daiichi Sankyo, Inc., Arcus Biosciences, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Non–Small Cell Lung Cancer (NSCLC) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

About Thelansis:

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.