Charles River (CRL) Offers Access to Preclinical Cancer Research
Charles River Laboratories International, Inc. CRL recently announced the ability to undertake preclinical cancer research utilizing ITCC-P4's well-characterized library of 400 annotated pediatric cancer models. As a global partner, Charles River provides clients access to this collection.
Charles River provides a wide range of oncology drug development and discovery services, including help with biologic medicines, model selection and safety evaluation.
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Over the past five years, Charles River has contributed to 84 percent of the FDA-approved cancer medicines and has provided our partners with 16 oncology prospects. The business is uniquely positioned to assist researchers in advancing their studies and navigating these new guidelines.
Given that all cancer medications must be evaluated for pediatric indications prior to approval under the FDA’s study to Accelerate Cures and Equity (RACE) for Children Act, the company is providing essential models for study. Furthermore, the European Medicines Agency's (EMA) regulations in the EU are being modified to align with the FDA's.
Significance of ITCC-P4
Researchers can adequately examine targets of interest using the ITCC-P4 repertory, which eventually increases translation to preclinical trials. The repertoire provides access to models that are relevant to pediatric cancer. An auxiliary dataset that includes molecular phenotyping and pharmacological characterization supported by the knowledge of internationally renowned pediatricians is provided to the ITCC-P4 collection. Charles River is combining decades of expertise in oncology research with a potent tool that will help guide important investigative decisions by making this collection available.
Per Charles River management, globally, 400,000 children and adolescents develop cancer each year, and nearly one in four cannot be cured with currently available therapies. The ITCC-P4 collection is comprehensive, relevant, and well-characterized. With this, the company can better assess the safety and efficacy of new oncology treatments for children. This will eventually lead to new treatment options for a critically important patient population.
Industry Prospects
Per a report by Allied Market Research, the global oncology drugs market size was valued at $135,494.17 million in 2020 and is projected to reach $274,400.63 million by 2030, registering a CAGR of 7.5% from 2021 to 2030. The growth of the oncology/cancer drugs market is driven by the increased prevalence of cancer disease and a rise in the incidence of various cancer conditions, increased popularity of advance therapies (biological and targeted drug therapies) and a surge in the geriatric population worldwide.
Developments among Peers
Within oncology drug development, companies like Pfizer PFE, Johnson & Johnson JNJ and Merck & Co. MRK are also making significant progress.
In October 2023, Pfizer announced that the FDA had approved its supplemental new drug applications (sNDAs) seeking label expansion for Braftovi (encorafenib) + Mektovi (binimetinib) in adult patients with BRAF V600E-mutant metastatic non-small cell lung cancer (“NSCLC”). Following the label expansion, the Braftovi/Mektovi combination is approved for two indications in the United States. The combination is approved for treating adult patients with BRAF V600E or V600K mutated metastatic melanoma. Braftovi, in combination with cetuximab, is also approved to treat adult patients with BRAF V600E-mutated metastatic colorectal cancer.
In September 2023, Johnson & Johnson announced positive top-line data from a late-stage study evaluating a chemotherapy-free regimen of its drug, Rybrevant (amivantamab-vmjw), for treating EGFR-mutated first-line non-small cell lung cancer (NSCLC). JNJ’s Rybrevant is currently approved for treating adult patients with locally advanced or metastatic NSCLC whose disease has progressed on or after platinum-based chemotherapy.
In September 2023, Merck announced that the FDA had accepted its supplemental biologics license application (sBLA), seeking expanded use of its blockbuster PD-L1 inhibitor, Keytruda, in cervical cancer. With the FDA granting priority review to the sBLA, a final decision is expected on Jan 20, 2024. MRK’s Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States.
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