The FDA has expanded the approved use of ibrutinib (Imbruvica) in chronic lymphocytic leukemia (CLL) to include patients with the chromosome 17p deletion, the agency announced today. This deletion has been associated with a poor response to standard CLL treatments, the FDA explained.
Full Answer
When was ibrutinib approved by FDA for CLL?
January 28, 2019 – The U.S. Food and Drug Administration (FDA) approved the use of ibrutinib (IMBRUVICA) in combination with obinutuzumab (GAZYVA) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Is there an alternative to Imbruvica?
In this case, we would have recommended discontinuation of ibrutinib and a switch to an alternative therapy, such as venetoclax with or without rituximab, idelalisib, or duvelisib, which have a lower reported incidence of atrial fibrillation and bleeding risk.
How long can you live taking Imbruvica?
The average duration of Imbruvica therapy in clinical trials has been around 41 months (range, 2–51 months). In people who have stopped Imbruvica, the average survival after treatment discontinuation was 8 months.
What is the success rate of Imbruvica?
Imbruvica + Rituxan as Initial Therapy After 4 years of follow up 89% of newly diagnosed CLL patients treated with Imbruvica survived without leukemia progression compared to 71% of FCR treated patients. More importantly, 99% of Imbruvica treated patients were alive compared to 91% of FCR treated patients.
What are the latest treatments for CLL?
In May 2019, the FDA approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) to treat people with previously untreated CLL as a chemotherapy-free option. In April 2020, the FDA approved a combination therapy of rituximab (Rituxan) and ibrutinib (Imbruvica) for adult patients with chronic CLL.
What is the difference between ibrutinib and Imbruvica?
Imbruvica™ is the trade name for the generic drug ibrutinib. In some cases, health care professionals may use the generic name ibrutinib when referring to the trade name Imbruvica™.
Can you live 20 years with CLL?
CLL has a very high incidence rate in people older than 60 years. CLL affects men more than women. If the disease has affected the B cells, the person's life expectancy can range from 10 to 20 years.
Can Imbruvica cause death?
Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA®, and can also be serious and may lead to death.
Can Imbruvica cure CLL?
Imbruvica Improves Outcomes in CLL, But Less Toxic Treatments Still Needed. Regimens containing Imbruvica bested chemoimmunotherapy treatments in elderly patients with chronic lymphocytic leukemia, but less toxic and long-term treatments are still needed.
How effective is ibrutinib for CLL?
Clinical trials leading to ibrutinib approval The efficacy and tolerability of ibrutinib were initially demonstrated in a phase I study, which showed an overall response (OR) rate of 60% and a complete remission (CR) rate of 16% in patients with relapsed/refractory CLL (Supplementary Fig.
How long does ibrutinib work for CLL?
Single-agent ibrutinib continued to demonstrate strong results after 7 years of follow-up in both the frontline and heavily pretreated, relapsed/refractory setting for patients with CLL and SLL.
How long has ibrutinib been around?
It was approved by the US Food and Drug Administration (FDA) on November 13, 2013, for the treatment of mantle cell lymphoma. On February 12, 2014, the FDA expanded the approved use of ibrutinib to chronic lymphocytic leukemia (CLL).
Dive Brief
The FDA has approved Imbruvica for first line treatment of chronic lymphocytic leukemia (CLL), a blood cancer which primarily affects the elderly, co-developer Janssen said on Friday.
Dive Insight
The first line indication greatly broadens the population of patients who could be treated with Imbruvica. This is a major win for Abbvie . The Illinois-based company spent $21 billion last year to buy Pharmacyclics, one the original developers, and has blockbuster hopes for the drug.
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