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SEC recommends approval of additional indication for BMS' anti-cancer drug nivolumab
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Gireesh Babu, New Delhi
November 19 , 2024
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The Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), has recommended approval of additional indication of US-based Bristol-Myers Squibb's anti-cancer drug nivolumab 10 mg/ml concentrate for solution for infusion with waiver of local phase III clinical trial.
The recommendation came in a recent meeting of the SEC for oncology, where the company presented the proposal for approval of the additional indication, that is nivolumab in combination with cisplatin and gemcitabine, indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The company requested a local phase III clinical trial waiver.
The company's product is branded as Opdivo and the 10 mg/ml injection 10 ml vial, according to online pharmacy stores, has a maximum retail price of Rs 50,000.
It also presented the safety and efficacy data from the global clinical studies where India is not a part of the study. The committee, however, noted that the proposed indication of the drug is approved in the US, Europe, UK, Canada and Brazil.
"After detailed deliberation, the committee recommended for approval of additional indication of nivolumab 10mg/ml concentrate for solution for infusion i.e. 'Nivolumab in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma' with a waiver of local phase III clinical trial and with the condition that firm is required to conduct phase IV clinical trial in Indian population for the proposed indication," said the SEC minutes.
Accordingly, the protocol to conduct the phase IV study shall be submitted within 3 months of grant of permission of additional indication, it added.
The company, in May, this year, announced that it received European Commission approval for the combination based on results from CheckMate-901, the first phase 3 trial in this patient population with an immunotherapy-chemotherapy combination to demonstrate survival benefit versus standard-of-care chemotherapy alone.
With this approval, Opdivo in combination with cisplatin and gemcitabine becomes the first concurrent immunotherapy-chemotherapy approved for the treatment of adult patients with unresectable or metastatic UC in the first-line setting in the European Union, said the company on May 29, 2024.
In CheckMate -901, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone, as assessed by Blinded Independent Central Review (BICR). The safety profile was consistent with the known safety profiles of the individual components of the regimen. No new safety concerns were identified, it said.
Opdivo, as a single agent, indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. It is also indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. It is also used in combination with ipilimumab as first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma and adult patients with metastatic non-small cell lung cancer in certain cases.
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