Sun Pharma launched therapeutic equivalent to Gleevec® in the US market. Sun Pharma’s subsidiary received final approval for Imatinib Mesylate from FDA in December 2015.
Gleevec is marketed by Novartis and it is a tyrosine-kinase inhibitor used in the treatment of multiple cancers, most notably Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia.
IMATINIB MESYLATE - INDICATIONS AND USAGE
- Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase
- Patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy
- Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
- Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements
- Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown
- Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1- PDGFRα fusion kinase negative or unknown
- Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)
As stated in the FDA approval letter, Sun Pharma’s Imatinib Mesylate did not seek approval for the method of treatment covered under U.S. Patent No. 6958335 ('335 patent).
According to the FDA’s Orange Book, the ’335 patent covers the “indication for the treatment of patients with KIT (CD117) positive unrespectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).” As a result, FDA has not approved Sun Pharma’s Imatinib Mesylate Tablet products for this indication.
Sun Pharma has established a Hub service where patients can dial-in to speak with a trained healthcare professional and discuss Imatinib Mesylate when used for indications approved by FDA under Sun Pharma’s ANDA.
