Amgen 2015 Annual Report Download - page 11

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3
• In December 2015, we announced that we submitted to the EMA a Variation to the MAA to expand the indication for
Kyprolis® in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have
received at least one prior therapy based on the data from the ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study
of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma)
trial.
• In January 2016, we announced that the FDA approved the sNDA of Kyprolis® in combination with dexamethasone or
with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who
have received one to three lines of therapy. The FDA also granted full approval for Kyprolis® as a single agent for the
treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. The
combination with dexamethasone was approved based on the ENDEAVOR trial.
Neulasta® (pegfilgrastim)
• In March 2015, we announced the Neulasta® Delivery kit, now known as the Neulasta® Onpro™ kit, was available in the
United States. The Neulasta® Onpro™ kit includes a specially designed single-use prefilled syringe co-packaged with the
new On-body Injector for Neulasta® that enables the healthcare provider to initiate administration of Neulasta® on the
same day as chemotherapy—with delivery of the patient’s full dose of Neulasta® the day following chemotherapy
administration, consistent with the Neulasta® prescribing information. This eliminates the need for patients to return to
their healthcare provider the day after chemotherapy, which would otherwise be needed to receive the Neulasta® injection.
Trebananib
• In April 2015, we announced that we stopped administration of blinded investigational product in the phase 3 study of
trebananib in first-line ovarian cancer based on a recommendation by the Data Safety Monitoring Committee.
Vectibix® (panitumumab)
• In April 2015, we announced that the EC approved a new use of Vectibix® as first-line treatment in combination with
FOLFIRI for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC).
• In June 2015, we announced that the phase 3 study evaluating Vectibix® and best supportive care (BSC) compared to
BSC alone in patients with chemorefractory wild-type KRAS (exon 2) mCRC, met its primary endpoint.
Bone health
Prolia® (denosumab)
• In June 2015, we announced that the phase 3 study evaluating the treatment effect of adjuvant Prolia® therapy in
postmenopausal women with early hormone receptor positive breast cancer receiving aromatase inhibitor therapy, met
its primary endpoint.
Romosozumab
• In September 2015, we and UCB, our collaboration partner in the development of romosozumab, announced that the
open label phase 3 STRUCTURE (STudy evaluating effect of RomosozUmab Compared with Teriparatide in
postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy) trial
met its primary endpoint.
Biosimilars
• In September 2015, we and Allergan plc (Allergan), our collaboration partner in the development and commercialization
of biosimilar candidate ABP 215, announced that a phase 3 study of ABP 215 compared with Avastin® (bevacizumab)
met its primary and secondary endpoints.
• In January 2016, we announced that the FDA accepted for review our Biologics License Application (BLA) for ABP 501,
a biosimilar candidate to Humira® (adalimumab). The FDA has set a September 25, 2016, Biosimilar User Fee Act target
action date. In addition, in December 2015, we announced that we submitted an MAA to the EMA.