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US FDA issues guidance on clinical trial for approval of non-small cell lung drugs, biologics
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Nandita Vijay, Bengaluru
April 29 , 2015
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The US FDA has issued guidelines for clinical trials related to the
approval of non-small cell lung (NSCL) drugs and biologics. The purpose
of the guidance is to evaluate drugs to treat lung cancer.
The
regulatory authority has clearly stated that for regular approval of a
new drug applications (NDA) and biologics license applications (BLA),
the applicant must show direct evidence of clinical benefit. It has now
quickened the approval pathway for approval of drugs or biological
products that are intended to treat serious or life-threatening diseases
like the non-small cell lung and that provide a meaningful therapeutic
benefit over existing treatments.
The American Cancer Society
estimated that there would be nearly 2,28,190 new cases of lung cancer.
In fact, lung cancer accounts for approximately 14 per cent of all new
cancers and it is the leading cause of fatality, accounting for about 27
per cent of all cancer deaths. Evaluation of new drugs for the
treatment of lung cancer is based on well-conducted and controlled
trials to assess and establish clinical benefit of the therapy.
According
to Kidwai Institute of Oncology, Bengaluru which is largest government
run cancer care in Karnataka, the need for a guidance was found wanting
because it was critical to bring in clarity on the treatment options.
The
regulator has said that specifically, speedy approvals may be based on a
clinical benefit; or can be measured in terms of being able to reverse
morbidity. In the past, three commonly used efficacy in trials assessing
treatments of lung cancer were overall survival (OS), time to
progression (TTP) or progression-free survival (PFS), and objective
tumour response rates (ORR).
Reduction in patients’ of
tumour-related symptoms have also been used as an efficacy endpoint. The
majority of drug approvals for non-small cell lung have been based on a
significant improvement in overall survival, as the median survival was
relatively short which is less than a year.
In addition, overall
survival is an optimal endpoint because the measurement is accurate, is
observed on a daily basis. It provides direct evidence of clinical
benefit to the patient. Regular approval was granted on the basis of a
significant improvement in overall survival. Similarly, reduction in
patients’ tumour-related symptoms can also provide direct evidence of
clinical benefit and can support regular approval.
The criteria
for disease progression and tumour response are based on subjective
interpretation of radiographic images and clinical evaluation. These
subjective interpretations have potential to introduce bias,
particularly when evaluated in open-label trials.
Specifically,
primary lung tumours and regional nodal disease frequently have
ill-defined borders that can be difficult to accurately measure
radiographically. Therefore, confidence in tumour measurement-based
outcomes depends on the frequency of assessments as well as clear,
objective criteria for defining disease progression and tumour response,
said the regulatory authority.
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