UK Greenlights Amgen's Drug For Aggressive Lung Cancer In Pretreated Patients

On Monday, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) granted a conditional marketing authorization to Amgen Inc’s (NASDAQ:AMGN) Imdylltra for extensive-stage small cell lung cancer with disease progression on or after at least two prior lines of therapy.

Small cell lung cancer is an aggressive lung cancer subtype that accounts for approximately 15% of lung cancers.

ES-SCLC is characterized by rapid tumor growth and metastatic spread.

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Patients with SCLC are often diagnosed after the cancer has reached an advanced stage because symptoms do not typically appear early in the disease.

"The MHRA's granting of a conditional marketing authorization for tarlatamab is a significant step forward for people living with small cell lung cancer. More than 34,000 people die from lung cancer in the UK each year," said Tony Patrikios, executive medical director, Amgen UK & Ireland.

The conditional marketing authorization is based on results from the Phase 2 DeLLphi-301 study, which evaluated tarlatamab in patients with ES-SCLC who had failed two or more prior lines of treatment.

Results from the study found that tarlatamab at the 10 mg every two weeks dose (N=99) demonstrated an objective response rate of 41% and a median duration of response of 9.7 months.

Price Action: AMGN stock is down 0.12% at $260.75 at last check Monday.

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