AbbVie Pulls Phase III Lung-Cancer Drug; FDA OKs Kyowa Kirin’s Parkinson’s Drug

AbbVie Terminates ADC Drug Candidate Rova for Lung Cancer

AbbVie reports that that Meru, a Phase III trial evaluating Rova-T (rovalpituzumab tesirine), a therapy for treating advanced small-cell lung cancer, is being closed and the Rova-T research and development program has been terminated.

Meru is a Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of Rova-T as maintenance therapy following first-line, platinum-based chemotherapy in small-cell lung cancer. Rova-T is an investigational antibody-drug conjugate (ADC) targeting the cancer-stem cell-associated delta-like protein 3 (DLL3), which is expressed in more than 80% of small-cell lung cancer patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue. AbbVie says Rova-T combines a targeted antibody with a cytotoxic agent that is delivered directly to the DLL3-expressing cancer cells.

An Independent Data Monitoring Committee recommended terminating Meru due to lack of survival benefit for patients receiving Rova-T compared with the placebo control arm based on results at a pre-planned interim analysis.

AbbVie says it will move forward prioritizing other development programs within its oncology pipeline.

Source: AbbVie


Kyowa Kirin Receives FDA Approval for Parkinson’s Disease Drug Nourianz

The US Food and Drug Administration (FDA) has approved Japanese specialty drug company Kyowa Kirin’s Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.

Regarding patients with PD, an “off” episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremors and difficulty walking.

According to the National Institutes of Health, PD is the second-most common neurodegenerative disorder in the US after Alzheimer’s disease. It happens when cells in the brain, which produce a chemical called dopamine, become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movements such as eating, writing and shaving.

Source: FDA

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