New Delhi: To reduce hospital trips of cancer patients during Covid outbreak, the US Food and Drug Administration (FDA) Tuesday approved an oral therapy to treat blood cancer.
The American regulator has approved a drug, named ‘Inqovi’, which, in tablet form, can be used for the treatment of adult patients suffering from myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
The drug is a combination of ‘decitabine and cedazuridine’, which are used as agents for chemotherapy — a treatment that uses strong medications to kill fast-growing cells in the body.
According to a statement by the FDA, the approval represents an important move in treatment options for patients with blood cancer, “who previously needed to visit a health care facility to receive intravenous therapy”.
It is a significant move as cancer patients are highly susceptible to Covid-19 infections due to their compromised immunity.
The life-long drug manufactured by the US-based Astex Pharmaceuticals could be imported by Indian patients after securing written permission from treating doctors and regulatory agency, the Drug Controller General of India.
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May not be affordable for Indian patients
According to Dr Rahul Bhargava, Director and Head, Haematology, Haemato-Oncology and Bone Marrow Transplant, Fortis Memorial Research Institute, Gurugram: “Myelodysplastic syndrome is common in India and affects 1 per million in Indian population. It is generally being diagnosed around 55-57 years of age, a decade younger than American population.
“The approval of the drug was one of the most awaited therapies as cancer patients need to continue this treatment until they are alive to increase their chances of survival,” he added.
“But the cost of the imported drug may not be affordable for a large section of patients. It hovers around $20,000 for one dose whereas the generic injections (presently) available in India costs just Rs 5,000 per dose,” he added.
Drug approved on ‘priority’ basis
One tablet of Inqovi is taken once daily for five consecutive days of each 28-day cycle, the FDA said.
The drug will help in reducing the pain of injections, weekly trips to hospitals, chances of acquiring hospital-based infections and expenses related to hospitalisation.
The FDA, in its statement, also said it is focusing more on providing options to patients with cancer with “regimens that can be taken at home”.
“The FDA remains committed to providing additional treatments to patients during the coronavirus pandemic. In this case, the FDA is making available an oral outpatient treatment option that can reduce the need for frequent visits to health care facilities,” said Richard Pazdur, director, FDA’s Oncology Center of Excellence, in the statement.
The drug was approved on a “priority” basis. The safety profile of the drug showed results similar to that of the intravenous decitabine treatment.
“Additionally, about half of the patients, who were formerly dependent on transfusions were able to no longer require transfusions during an 8-week period. The safety profile of Inqovi was also similar to intravenous decitabine,” the FDA said.
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