The New Drugs Advisory Committee on Oncology and Haematology, under the Drugs Controller General of India (DCGI) office, has asked Lupin to hold fresh study with proper design for effectiveness assessment of safety and efficacy of its new drug in prevention of treatment of chemotherapy induced thrombocytopenia in adult cancer patients.
“The Committee opined that the marketed authorization cannot be granted on the basis of the data provided by firm. Therefore committee recommended that a new study with proper design should be initiated for effective assessment of safety and efficacy of this new drug in prevention of treatment of chemotherapy induced thrombocytopenia in adult cancer patients. The number of study centre should be adequate and geographically distributed in the country,” according to an official sources.
The expert panel, which met recently, took up 18 proposals, most for clinical trials. It recommended approval for permission of studies in most cases, based on the data and on the ground that many of them were already marketed in several countries.
While considering the application by Sandoor Medicals, the committee opined that the drug Clofarabine is marketed in more than 40 countries. The drug has been approved in other countries based on CT data on 62 patients only. The drug is indicated for a rare disease, for which currently there is no therapy. Therefore committee opined that the request for the waiver of clinical trial/pharmacokinetic study in Indian patients can be considered for this drug. However before recommended for import and market of Clofarabine, the firm should submit the PMS data generated so far with the drug which should be provided to the members for examinations and final recommendation on the proposal.
The panel, considering the application by CD Pharma for its Lctobacillus Brevis Loengers (CD2 400mg), has asked for multi-centric statistically powered phase III trials in the proposed indications in sites geographically distributed in the country, as clinical data was inadequate.
Eli Lilly had submitted the application for its Pemetrexed Disodium Powder for solution for injection and panel noted that the drug was already approved in the country for various indications. “The firm presented the phase III clinical trial data conducted in India as a part of global trial in the proposed indication in 939 patients globally. In the study there are 54 patients from India in induction phase which reduced to 21 patients in maintenance phase. The drug is approved in proposed indication in many countries in EU. However it is under review by US FDA. Therefore the committee recommended for approval of the drug for proposed additional indication,” an official note said.
Lincoln Pharmaceuticals presented the reports of bioequivalent study conducted with the Ondansetron oral spray with Ondansetron mouth dissolving tablet. The result shows that both are bioequivalence. Hence, no other clinical trial is required. The oral spray of Ondansetron is advantageous over Ondansetron tablet as in some patients who cannot swallow the tablet, the drug can be administered in proposed form of oral spray. Therefore the committee recommended for giving permission to manufacture and market Ondansetron oral spray.
Megestrol Acetate USP oral suspension (400 mag/10ml) by LG Life Sciences also got nod from the panel which viewed that the drug was very old and marketed as tablet in the same dosage also.
The committee also recommended permission to conduct trials for Vadetanib and Axitinib from Quintiles while its application for trials of Radotinib was withdrawn after the sponsor decided not to include India in the global study due to the delay in the review and approval.
In the case of Afatinib by Boehringer, the panel recommended permission for the trials subject to condition that upper age limit should be 65 years. While giving permission to Inc Research (GVK-BIO) for trials, the panel asked the company to exclude locally advanced soft tissue sarcoma patients from the study.