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What Amgen Expects from Blincyto in 2017

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Blincyto’s revenue trends

In 2Q17, Amgen’s (AMGN) Blincyto generated revenues of ~$43 million, which represented ~43% growth on a YoY (year-over-year) basis. Blincyto (blinatumomab) is an injection for the treatment of adults and children with relapsed or refractory B-cell precursor ALL (acute lymphoblastic leukemia).

For more on Blincyto and its revenue prospects, please refer to Market Realist’s “Blincyto Could Achieve High Volume Growth in 2017.”

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Recent approval

In July 2017, the FDA (US Food and Drug Administration) approved Amgen’s sBLA (supplemental Biologics License Application) for Blincyto to include OS (overall survival) statistics from its phase-3 Tower trial.  Amgen’s sBLA also included statistics from its phase-2 Alcantara trial, which showed the safety and efficacy of Blincyto in the treatment of individuals with Ph+ (Philadelphia chromosome-positive) relapsed or refractory B-cell precursor ALL.

This regulatory approval should help label expansion of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL.

The Tower trial

The Tower trial demonstrated that patients on Blincyto showed a median OS of 7.7 months, compared with four months for patients on SOC (standard of care) chemotherapy. The Tower trial also demonstrated that 34% of the patients on Blincyto therapy achieved complete remission compared to 16% of patients on SOC chemotherapy.

Among the patients receiving Blincyto, 44% patients achieved CR (complete remission) or CR with partial or incomplete hematologic recovery, compared with 25% patients receiving SOC chemotherapy. Among patients with CR or CR with partial or incomplete hematologic recovery, 76% patients on Blincyto achieved MRD (minimal residual disease) negative status, compared with 48% of patients receiving SOC chemotherapy.

Notably, Amgen’s Blincyto faces competition from Novartis’ (NVS) Gleevec, Bristol-Myers Squibb’s (BMY) Sprycel, Ariad Pharmaceuticals’ Iclusig. In February 2017, Takeda Pharmaceuticals (TKPYY) completed the acquisition of Ariad Pharmaceuticals. Notably, the iShares Core S&P 500 ETF (IVV) invests ~0.60% of its total portfolio holdings in AMGN.

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