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FDA APPROVED FOR LEUKEMIA! – Copiktra

People who are a victim to Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia or Follicular Leukemia (FL) face the disease in either relapsing or recurring conditions. A drug has been recently approved by FDA for treating these types of blood cancer. It is named as Copiktra which is a dual Inhibitor of PI3K delta and PI3K [...]

People who are a victim to Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia or Follicular Leukemia (FL) face the disease in either relapsing or recurring conditions.

A drug has been recently approved by FDA for treating these types of blood cancer. It is named as Copiktra which is a dual Inhibitor of PI3K delta and PI3K gamma and is administered in the form of capsules. Copiktra is used for treating FL in patients who have received two prior systematic therapies.

It wasn’t easy to get the drug approved and a randomized open-label trial helped to achieve its approval. Arzerra (Ofautmumab) was a drug compared in a trial with Duvelisib. Patients were either administered with Arzerra or Duvelisib

Arzerra group got 300 mg of the drug once in a week initially, which later became 2000 mg once weekly in 7 doses and then, 2000 mg split in 4 weeks. Copiktra group patients were given 25 mg of dose each day. Progression Free Survival (PFS) in patients treated with Copiktra was of 16.4 months while 9.1 in case of Arzerra. 78% and 39% was the overall response rate of Copiktra and Arzerra, respectively.

Single arm, the multicenter trial got the drug approved for FL where 83 patients who were being treated by Rituxan and other therapies were included. Overall Response Rate was 42 in which one had a complete response while others responded partially. Another group of 35 people should a different response rate and time.

FDA approved the drug for FL stating that disease might differ in different groups under trial.

The drug has many common and some serious side effects as well. They include infection, diarrhea, skin reactions, pneumonitis, hepatotoxicity, neutropenia, rash fatigue, pyrexia, cough, and respiratory infections.

Meghan Gutierrez gives a statement about blood cancer patients in which she says that such patients are always in a hope of new therapies like Copiktra because these are crucial to them. Every person’s story is different. In her statement, Meghan appreciates the companies which are struggling to cure lymphoma, like Verastem Oncology.

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