Doctors from Mumbai's Tata Memorial Centre, in collaboration with IDRS Labs in Bengaluru, have developed India's first and only chemotherapy drug, 6-mercaptopurine (6-MP), available in syrup form. This development is crucial in combating Acute Lymphoblastic Leukemia (ALL), the most common form of blood cancer affecting children.Around 10,000 children aged 1-10 years diagnosed with ALL are expected to benefit from the drug annually. The newly developed syrup form of 6-MP effectively addresses challenges associated with the existing tablet formulation. This innovation provides solutions for dosage precision, flexibility, and tolerability. While liquid formulations of 6-MP have been available in Europe and the US for an extended period, children in India and other developing countries previously lacked access to such alternatives.
The child-friendly formulation is presented in the form of a powder for oral suspension. It is reconstituted into a 100 ml oral suspension at a concentration of 10mg/ml. This innovative solution eliminates less-than-ideal practices like tablet crushing or alternate-day dosing that were previously employed to meet specific dosing needs in children.Dr S D Banavali, Director-Academics at Tata Memorial Centre, Mumbai, and a senior pediatric hemato-oncologist, emphasised that conventional tablets often come in 50mg formulations, making it challenging to meet the specific dosage needs of children, which are usually in the range of 22ml or 37ml. He stated that syrup absorption is more effective, reducing the risks of underdosing or overdosing.
PREVALL has received approval from the Central Drugs Standard Control Organization (CDSCO), the national drug regulatory body. The results of the clinical study leading to regulatory approval were jointly published by Tata Memorial Centre, the Advanced Centre for Training Research and Education in Cancer (ACTREC), Navi Mumbai, and IDRS Labs in the scientific journal Pediatric Blood and Cancer recently. The formulation was introduced in Tata Hospital in early December and is expected to be available in all major hospital pharmacies across the country soon.Dr Girish Chinnaswamy, Professor and head of the Department of Pediatric Oncology at Tata Hospital, highlighted that formulations like PREVALL would play a crucial role in ensuring dose optimisation, improving adherence, and maximising efficacy. The syrup comes with a syringe and a Press In Bottle Adapter (PIBA) for precise dosing tailored to a patient’s body weight or surface area, eliminating spillage and caregivers’ exposure to cytotoxic compounds.
