AZ cancer treatment gets FDA priority review
Lilly’s pancreatic cancer treatment fails late-stage study
NEW YORK, Oct 17, (RTRS): AstraZeneca Plc (AZ) said on Thursday that the US drug regulator will give a speedy review to its experimental breast cancer treatment, which could put the British drugmaker in direct competition with bigger rival Roche Holding AG.
The US Food and Drug Administration (FDA) accepted AstraZeneca’s application and granted the treatment, trastuzumab deruxtecan, a priority review for the treatment of HER2-positive metastatic breast cancer, the drugmaker said.
The London-listed company in March agreed to pay up to $6.9 billion to work with Japan’s Daiichi Sankyo on the treatment, in a direct challenge to the world’s biggest cancer drug maker Roche.
The treatment, also known as DS-8201, targets the HER2 protein, a major trigger of uncontrolled cell growth in about 20% of breast cancer cases. It is an area where Roche has been a pioneer with its best-seller Herceptin.
DS-8201 is part of a drug class called antibody-drug conjugates (ADC), which link powerful cell toxins to antibodies that cling to cancer cells, sparing the healthy cells that are damaged during conventional chemotherapy treatments.
The treatment showed promise in a mid-stage clinical trial in May, data from which formed part of the basis for AstraZeneca’s application to the FDA.
The expedited review is part of the FDA’s process to bring medications for serious or rare conditions faster to the market, taking about six months for a decision, compared to the standard 10 months.
The FDA’s decision on trastuzumab deruxtecan is expected in the second quarter of next year.
AstraZeneca, which is set to report third-quarter results next week, has been betting on cancer medicines, an area of increasing focus after years of crumbling sales due to patent losses on older drugs.
Also: NEW YORK: Eli Lilly and Co said on Wednesday its experimental pancreatic cancer treatment in combination with chemotherapy drugs failed to meet the main goal of overall survival in a late-stage study.
The trial evaluated Lilly’s pegilodecakin plus Folfox, which is a combination of chemotherapy drugs, compared to Folfox alone in patients with metastatic pancreatic cancer.
Lilly, which gained access to pegilodecakin with its $1.6 billion acquisition of Armo Biosciences in 2018, said it would conduct trials in lung cancer and other tumor types including renal cell carcinoma, where the molecule has shown promising activity.
Pegilodecakin is a naturally occurring immune growth factor called a pegylated interleukin-10 that stimulates the survival, expansion and killing potential of a particular type of white blood cell in the immune system.
Metastatic pancreatic cancer is one of the deadliest major cancers, with just 3% of patients in the US living five years after the cancer is diagnosed.