Amgen files novel cancer immunotherapy

Amgen has submitted its new immunotherapy treatment for acute lymphoblastic leukaemia (ALL) with the FDA.

The novel drug, called blinatumomab, is the first in a new class of antibodies which help the body’s immune system to detect and target malignant cells. Blinatumomab is a bispecific T cell engager (BiTE) antibody construct to treat adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukaemia (ALL).

Blinatumomab has received both orphan drug designation and breakthrough therapy designation from the FDA for the treatment of ALL.

The company’s submission includes data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint.

“Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL,” said Anthony S. Stein, M.D., clinical professor, Hematology/Oncology at City of Hope. “Blinatumomab has the potential to significantly advance treatment options for patients living with this difficult-to-treat disease, and the BLA submission marks an important step toward achieving this goal.”

In the US, it is estimated that more than 6,000 cases of ALL will be diagnosed in 2014, and in the European Union, more than 7,000 cases of ALL are diagnosed each year. In adult patients with relapsed or refractory ALL, median overall survival is just three to five months.

“We look forward to working with regulatory authorities to make blinatumomab available for adult patients with acute lymphoblastic leukaemia, who experience high relapse rates and have limited treatment options,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

The first of many haemato-oncology indications

The drug’s use in ALL is likely to be just the first of many indications.

Amgen has received orphan drug designation from the FDA for the treatment of ALL, chronic lymphocytic leukaemia (CLL), hairy cell leukaemia, prolymphocytic leukaemia and indolent B-cell lymphoma. In Europe, the EMA has granted it orphan status for indolent B-cell lymphoma, ALL, CLL and mantle cell leukaemia (MCL).

In CLL in particular, Amgen’s drug will face stiff competition from two other recent entrants to the market – Janssen’s Imbruvica (ibrutinib) Gilead’s Zydelig (idelalisib), which have been launched in the US this year, and are set to hit Europe in the next few months.

Blinatumomab is also being investigated for its potential to treat paediatric relapsed/refractory ALL, relapsed/refractory Philadelphia positive (Ph+) B-precursor ALL, minimal residual disease positive (MRD+) B-precursor ALL, relapsed/refractory non-Hodgkin’s lymphoma (NHL), including relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

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