Immuneel Launches Qartemi, a CAR T-cell Therapy for Non-Hodgkin's Lymphoma in India
• Immuneel Therapeutics has launched Qartemi, India's first CAR T-cell therapy for treating adult B-cell Non-Hodgkin Lymphoma (B-NHL).
• Qartemi is a personalized therapy that modifies a patient’s T-cells to target and eliminate cancer cells, offering hope for lasting remission.
• Clinical trials in India and Spain demonstrated that Qartemi's safety and efficacy are similar to US FDA-approved CAR T-cell therapies.
• Priced at approximately ₹35 to ₹50 lakh, Qartemi is significantly more affordable than similar treatments in the US.
India ICMR Partners with Industry to Advance Phase I Clinical Trials
• The Indian Council of Medical Research (ICMR) has formalized partnerships with industry and academic institutions to facilitate first-in-human phase one clinical trials for four novel pharmaceutical agents.
• The collaborations will support diverse research projects, including a CAR-T cell therapy study for chronic lymphocytic leukemia and trials for a small molecule targeting multiple myeloma.
• Four institutions across India will form a network to conduct these early-phase clinical trials, supported by infrastructure and manpower to ensure efficient trial execution.
• According to Dr. Rajiv Bahl, establishing a phase one clinical trial infrastructure is crucial for fostering the development of indigenous molecules and innovative treatments.
ICMR Partners with Industry to Advance First-in-Human Phase 1 Clinical Trials in India
• The Indian Council of Medical Research (ICMR) has signed agreements to advance first-in-human Phase 1 clinical trials for four molecules.
• Collaborations include research for multiple myeloma, Zika vaccine development, influenza vaccine trials, and CAR-T cell therapy advancements.
• This initiative aims to establish India as a leader in pharmaceutical clinical development and affordable healthcare solutions.
• The ICMR network includes four institutions across India, enhancing the capacity for early-phase clinical trials with robust infrastructure.
Osimertinib and Amivantamab Gain FDA Approval for EGFR-Mutated NSCLC
• Osimertinib receives FDA approval for unresectable Stage III EGFR-mutated NSCLC after chemoradiation, showing a significant increase in progression-free survival.
• Amivantamab, combined with chemotherapy, gains FDA approval for EGFR exon 19 deletions or exon 21 L858R substitution mutations in NSCLC after EGFR TKI treatment.
• Clinical trials, including LAURA and MARIPOSA-2, support these approvals, offering new targeted therapy options for patients with advanced NSCLC.
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