Crizotinib now FDA approved

[Bonni Hess]

Dear ASPS Community Friends,
Based on the following article,the Met inhibitor Crizotinib has now received FDA approval and may therefore be a candidate for insurance coverage. However, there is very limited available data thus far regarding the effectiveness of Crizotinib for ASPS patients, and I am not personally aware of any ASPS patients who have had a successful treatment response to Crizotinib. I would like to encourage anyone who has treatment experience with, and/or knowledge about, ASPS treatment success with Crizotinib, to share it with the Board so that people can make the most knowledgeable treatment decisions regarding this drug. Take care everyone.
With special caring thoughts and continued Hope,
Bonni


Oncology & Hematology
NSCLC: FDA Approves Crizotinib, Companion Diagnostic Test By: MARY JO M. DALES, Internal Medicine News Digital Network


Crizotinib has been approved to treat locally advanced and metastatic non–small cell lung cancers that express an abnormal anaplastic lymphoma kinase gene, the Food and Drug Administration announced on Aug. 26.

Crizotinib (Xalkori, Pfizer) was approved for the indication in concert with a companion diagnostic test for ALK gene abnormality, called the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.). Up to 7% of those with NSCLC – typically patients without a history of smoking – have the ALK gene abnormality. Crizotinib, a kinase inhibitor, is a single-agent oral therapy.

"The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the approval. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."

Crizotinib’s safety and effectiveness were established in two multicenter, single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC. The studies were designed to measure the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy.

In one study, the objective response rate was 50% with a median response duration of 42 weeks. In another, the objective response rate was 61% with a median response duration of 48 weeks.

Crizotinib was approved under the FDA’s accelerated approval program, which allows approvals based on clinical data showing a drug’s effect on an end point that is reasonably likely to predict clinical benefit. Further studies will confirm the drug’s clinical benefit.

The most common side effects reported in patients receiving crizotinib included vision disorders, nausea, diarrhea, vomiting, edema, and constipation. Crizotinib has also been associated with potentially life-threatening pneumonitis, which necessitates discontinuation of the drug. Pregnancy also is a contraindication for crizotinib use.

[Ivan]

Good news. Another possible weapon in the arsenal.

[Johannes]

Hello,

With Crizotinib / Xalkori now being FDA approved and available, do we know whether this could be a promising option for ASPS? My impression is that there is only very few data available for treatment of ASPS with Crizotinib, and I am not sure that ASPS tumors have been tested (stained?) for ALK.

Anyway, I noticed that a new Phase II Crizotinib trial, which specifically includes ASPS, should start recruiting patients in Europe in a few months:
http://clinicaltrials.gov/ct2/show/NCT0 ... oma&rank=6

What do you think?

Best,
Johannes

[Bonni Hess]

Dear Johannes,
As I said in my response under your today's "Other Clinical Trials" topic posting, I am aware of one former Board member who just recently received insurance approval to begin treatment with a combination of Crizotinib (Xalcori) and Pazopanib (Votrient). If the information is shared on the other sites, I will be closely following his treatment experience and results. I am holding very tight to Hope that he will have a very successful response, and that this will prove to be an effective new treatment option for all ASPS patients.
Thank you for the shared information about the upcoming Phase 2 Crizotinib Trial in Europe which specifically includes ASPS. I will be closely following and anxiously awaiting the results of this Trial.
With appreciation for the shared information, special caring thoughts, and continued Hope,
Bonni

[Johannes]

Thank you, Bonni!

All the best,
Johannes