New Delhi: The Indian Council of Medical Research (ICMR) has requested the Narendra Modi government’s panel of experts to approve testing of cancer drug acalabrutinib as part of the World Heath Organization’s global ‘Solidarity’ trial, which is testing drugs to find an effective treatment for Covid-19.
ICMR’s National AIDS Research Institute (NARI) — the institute responsible for conducting WHO’s trial in India — has presented the government’s Subject Expert Committee (SEC) with a proposal to amend Solidarity’s ongoing protocol by adding a trial arm to test acalabrutinib.
The SEC advises the country’s apex drug regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines and clinical trials.
The committee deliberated over the matter on 9 October and asked NARI for clarifications and justifications on the proposal to approve the addition of the arm.
Acalabrutinib is a cancer drug developed by British pharmaceutical giant AstraZeneca and is branded as Calquence.
In June, AstraZeneca had started phase 2 clinical trials of the drug to treat severe Covid-19 patients with respiratory failure in India as part of its global trial.
As part of the trial, the drug is presently being given to the Covid patients who develop pneumonia and require hospitalisation.
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Remdesivir results likely to be available in a few weeks: SEC
During the 9 October meeting, the SEC noted that remdesivir and dexamethasone are already being used for Covid treatment in the Solidarity trial.
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.
“However, as per the proposal, such patients included in Acalabrutinib arm may not receive these drugs,” the SEC said at the meeting, according to minutes uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website. The CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in the country.
The SEC also pointed out that “one global clinical trial of Acalabrutinib is ongoing in various countries including India”, referring to the trial by AstraZeneca.
Furthermore, the committee noted that the results on the efficacy of Remdesivir are likely to be announced soon. “During the presentation, the committee was informed that the results on Remdesivir from the Solidarity trial may be available in a few weeks.”
The minutes noted that after the “detailed deliberation” that more “clarification and justification for inclusion of Acalabrutinib arm in the Solidarity trial will be required before including the arm at present”.
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Efficacy of acalabrutinib in Covid
Acalabrutinib was approved by the US Food and Drug Administration last year for the treatment of certain types of cancers.
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.
In June, AstraZeneca had announced in peer-reviewed journal Science Immunology that the drug “reduced markers of inflammation and improved clinical outcomes of patients with severe Covid-19”.
According to the company’s website, “The science supporting investigation of the use of Calquence in patients with severe Covid-19 is strong.”
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