FDA-approved products Ponatinib (Iclusig) ARIAD developed Ponatinib (Iclusig), a tyrosine kinase inhibitor for the treatment of adult patients with Philadelphia chromosome-positive [Ph+]
chronic myeloid leukemia (CML), and acute lymphoblastic leukemia. On December 14, 2012 the
FDA approved ARIAD's leukemia drug Ponatinib for patients with all forms of Ph+ CML or Ph+
acute lymphoblastic leukemia (ALL) who are resistant to or unable to tolerate other
tyrosine kinase inhibitors. The drug was temporarily withdrawn from the U.S. market in November 2013 because of the risk of
blood clots and severe narrowing of blood vessels. Ponatinib was returned to the market in the U.S. on December 20, 2013 with revised prescribing information, new warnings and a REMS. ARIAD had set up an emergency-access program for Ponatinib, which provided drugs to patients in need during this six-week period. Ponatinib remained on the market in all European countries and was subsequently approved in Japan.
Brigatinib (Alunbrig) ARIAD’s product pipeline includes
brigatinib, an inhibitor of
anaplastic lymphoma kinase [ALK] for treating ALK+ non-small cell lung cancer. This drug reported results of its registration trial at ASCO, June 6, 2016, with encouraging results, leading to approval in the U.S. in April 2017. Brigatinib was designated a Breakthrough Medicine by the FDA.
Ridaforolimus (formerly Deforolimus, partnered with Medinol) Ridaforolimus is an
mTOR inhibitor being developed by Medinol Ltd for use in drug-eluting stents for patients with coronary artery disease. Medinol has completed two registrational trials in patients with coronary artery disease, which met its primary and secondary endpoints. In October 2017, Medinol’s EluNIR drug eluting stent, coated with ridaforolimus, received CE Mark in Europe.
Products under development Various company-sponsored and investigator-sponsored trials are ongoing in several indications, including first line and second line CML, acute lymphoblastic leukemia (BCR-ABL), acute myeloid leukemia (FLT3 inhibitor), non-small cell lung cancer (RET, FGFR), advanced biliary cancer with
FGFR2 fusions and other cancers with activating mutations involving the following genes:
FGFR1, FGFR2,
FGFR3,
FGFR4,
RET, and
KIT.
Rimiducid Rimiducid is an investigational chemical dimerizer being developed by partner, Bellicum Pharmaceuticals and is in Phase 3 clinical trials.
AP32788 AP32788 is a tyrosine kinase inhibitor of solid tumors with EGFR and HER2 activating mutation and began Phase 1/2 testing in the second quarter of 2016. ==See also==