Obinutuzumab is relatively new medication used for treating certain type of Blood Cancers. It is used for the treatment of Chronic Lymphocytic Leukemia, given along with chlorambucil. CLL is known to be one of the most common malignancies among leukemias, usually diagnosed in adults. New treatment options like Gazyva (Obinutuzumab) can offer better scope for survival compared to other routine treatments. Obinutuzumab price in India may be fixed by the local regulatory agency. Gazyva 25mg/mL (1000mg/40mL single-use vial) is commercially available in global markets. Gazyvaro is the alternative brand name for it. It is a product of Roche which has its international presence including India.
Gazyva (Obinutuzumab) FDA Approval Status
Obinutuzumab received its US FDA approval in November 2017. It was approved for treating relapsed or refractory follicular lymphoma in combination, as a combination drug. In CLL, it may be used along with Venetoclax and in FL, it may be used along with Bendamustine. As of now, Obinutuzumab is approved for adult patients and doesn’t have supportive data for pediatric patients.
- Gazyva or Gazyvaro has a unique mechanism of action. It acts by binding on to CD20 on B cells and eventually acts to kill the malignant B Cells. It acts by exploiting the adaptive immune system.
- Before the regular approval in 2017 by the FDA, Obinutuzumab received approval based on priority review in 2016. It has received yet another approval in 2019 treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Obinutuzumab in India – Procuring advanced medications like Gazyva / Gazyvaro
Gazyva (Obinutuzumab) India based sourcing will depend on the actual recommendation by a clinical hematologist. After the medical assessment of a patient’s suitability for this medication, experts will prescribe the ideal dosage and quantity required. This is mostly determined by the number of cycles planned by a treating physician. This comprehensive information is required to work on the optimal cost of Gazyvaro in India. International factors do impact the Obinutuzumab Price variations. Patients must spend time and efforts to identify the right global supplier who can deliver within the stipulated timelines. Patients who require specialized lifesaving medicines may be aware of the Named Patient Import options. The same options or provisions will be applicable to figure out the sourcing avenues for products including Gazyva. Transparency is often the right indicator of a reliable supplier of specialized medicines.
Standard procedure for sourcing products like Obinutuzumab
When in shortage, Gazyvaro (Obinutuzumab) can be imported only after due procedures are completed as specified by the CDSCO. It is an Indian authority that deals with the patient specific licenses. There are simple forms that are accessible online that can be duly filled and submitted. The respective authorities will verify the prescription and patient’s identity before issuing a specific permit to import medicines in limited quantities. Once the necessary permits are received, the important step is to work with a global supplier who can support through the international procedures. There are companies dedicated for these services in major cities of India. There are also several unauthorized suppliers who claim to offer services, but they may do deliver. Given these sensitivities, patients are advised to go for proper validation before finalizing the orders.
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