Inclusion of cancer drug in WHO Covid Solidarity trial: CDSCO panel asks ICMR to submit more clarification

The recommendation came after ICMR's National AIDS Research Institute (NARI) submitted before the Subject Expert Committee (SEC) with a proposal for amendment in the protocol, including the addition of one new arm of Acalbrutinib in the Solidarity trial.

Acalabrutinib is a cancer drug developed by British pharmaceutical giant AstraZeneca and is branded as Calquence. The drug belongs to a class of medications called Bruton's tyrosine kinase (BTK) inhibitor, which blocks the action of the abnormal protein that signals cancer cells to multiply, stopping the growth of cancer cells.

The committee deliberated over the matter and asked NARI for clarifications and justifications on the proposal to approve the addition of the arm.

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The committee noted that presently, Remdesivir and Dexamethasone are used as part of treatment in such COVID patients. However, as per the proposal, such patients included in the Acalabrutinib arm may not receive these drugs.

Remdesivir is an intravenous antiviral drug sold by US pharmaceutical company Gilead Sciences Inc. while dexamethasone is a steroid, which is part of India's approved clinical management protocol for Covid-19.

It further pointed out, "One Global clinical trial of Acalbrutinib is ongoing in various countries including India."

Furthermore, the committee stated that it was informed that during the presentation, the results on Remdesivir from the Solidarity trial may be available in a few weeks. Subsequently, the Committee held;

In view of the above, the committee after detailed deliberation recommended that more clarification/justification for inclusion of Acalabrutinib arm in the Solidarity trial will be required before including the arm at present.