One is enrolling platinum-resistant ovarian cancer patients who have failed standard therapy and have had no more than three lines of prior therapy
. The other cohort is enrolling NSCLC adenocarcinoma patients who have failed front line platinum-based chemotherapy, either in combination or sequentially treated with an anti-PD-1 or anti-PD-L1 therapy.
D842V mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy
, and fourth-line GIST.
DARZALEX is indicated in Europe for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy
included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
It will be made available to adult patients after prior therapy
Nivolumab is currently licensed in Ireland to treat adult patients with advanced kidney cancer who have received prior therapy
The marketing authorisation allows the product to be used in combination with chlorambucil or bendamustine to treat patients who have not received prior therapy
Food and Drug Administration (FDA) approval for IMBRUVICA (ibrutinib) capsules as a single, oral agent for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
. The drug was originally approved on November 13, 2013 for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
"Today, the distinct tolerability profile of BOSULIF offers physicians an important therapeutic choice for their patients with Ph+ CML, as has already been shown in patients who are resistant or intolerant to prior therapy
. Through our collaboration with Avillion, we plan to expand the development of BOSULIF by exploring its potential benefit as a first-line therapy for patients with CML."
Clavis will continue to concentrate on elacytarabine and its Phase III study dubbed CLAVELA in patients with acute myeloid leukaemia (AML) who have failed prior therapy
ChemGenex Pharmaceuticals Ltd., a company with offices in Australia and Menlo Park, Calif., is seeking approval of omacetaxine for the treatment of adults with chronic myeloid leukemia (CML) after failure on prior therapy
with imatinib (Gleevec) and with the Bcr-Abl T3151 mutation.
Sprycel is currently approved for treating adults with resistance or intolerance to prior therapy
for chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.