Astrazeneca’s Imfinzi Obtains US FDA Approval for Lung Cancer Treatment


US FDA approval of Astrazeneca for treatment of lung cancer and GSK limits second-line use of drug for malignant ovarian tumors

  • Astrazeneca has released an update on a treatment for non-small cell lung cancer
  • GSK will limit the use of its ovarian cancer treatment Zejula in the United States

AstraZeneca has received approval in the United States for a new treatment targeting adult patients with stage four metastatic non-small cell lung cancer.

The approval, which applies to the drug Imfinzi in combination with Imjudo plus platinum-based chemotherapy, was based on results from the Phase III Poseidon trial.

The company noted that patients treated with a limited course of five cycles of the Imjudo antibody added to Imfinzi, plus four cycles of platinum-based chemotherapy, experienced a 23% reduction in risk of death compared to a range other chemotherapy options.

An estimated 33% of patients were alive at two years, compared to 22% for chemotherapy alone. The combination of treatments also reduced the risk of disease progression or death by 28% compared to chemotherapy alone, AstraZeneca said in a statement today.

Update: AstraZeneca today released an update on its treatments for non-small cell lung cancer

Updated results from the trial demonstrated a lasting survival benefit, improving overall survival by 25% compared to chemotherapy alone, the pharmaceutical giant said.

Melissa Johnson, director of lung cancer research and Sarah Cannon, of the Tennessee Oncology Research Institute in Nashville, said: “Metastatic non-small cell lung cancer remains a significant treatment challenge because tumors many patients do not respond well to standard therapies, including checkpoint inhibitors.

“The approval of this dual regimen of immunotherapy with chemotherapy introduces a new, generally well-tolerated treatment option for patients with this devastating disease and gives them the opportunity to experience the long-term survival advantage seen with inhibition of CTLA-4.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval underscores the importance of providing novel combinations of treatments that prolong survival in metastatic non-small cell lung cancer. , a complex setting where many patients still face a dismal prognosis.

“This is the second indication for Imjudo added to Imfinzi in just weeks after its approval in unresectable liver cancer, reinforcing the benefits of this new drug and our commitment to improving patient outcomes in the context of cancer with ongoing unmet needs.”

Imfinzi is also approved in various countries for the treatment of extensive-stage small cell lung cancer based on the Phase III Caspian trial, AstraZeneca said.

On Wednesday, AstraZeneca said it raised its full-year profit forecast after a strong third quarter.

The company said it now expects its 2022 basic earnings per share at constant currencies to increase by a 20s to 30s percentage, up from previous guidance of an increase from the 20s to 30s. the twenteeth.

At actual exchange rates, EPS growth is expected to be impacted by a mid- to high-single digit currency headwind, compared to previous guidance of a mid-single digit headwind.

The turnover of the oncology branch of the Anglo-Swedish group increased by 24%, with sales up 20%.

The group saw revenue from non-profit contracts for its Covid-19 vaccine drop over the period. AstraZeneca is no longer seeking US approval for its US Covid-19 vaccine.

Shares of AstraZeneca fell today and fell 2.77% or 309.10p to 10,848.90p this afternoon, after rising more than 14% last year.

GSK will limit the use of an ovarian cancer drug in the United States

Pharmaceutical giant GSK has announced that it will limit the use of its ovarian cancer treatment Zejula in the United States.

Use will, according to the group, be limited to patients with specific mutations when given a second option to maintain their treatment, following a request from US authorities.

The drugmaker said it would limit the second-line maintenance indication for Zejula to only patients with harmful or suspected harmful inherited BRCA mutations, as requested by the U.S. Food and Drug Administration .

The first-line indication of Zejula in the United States remains unchanged for the maintenance treatment of adult patients with advanced epithelial cancer of the ovary, fallopian tube, or primary peritoneum who have a complete or partial response platinum-based chemotherapy.

GSK said, “This decision follows a review by the FDA of the final overall survival (OS) analysis from the ENGOT-OV16/NOVA Phase III trial, which served as the basis for approval. of the second-line maintenance indication.

“In the final OS results from the NOVA trial, the secondary OS endpoint demonstrated a hazard ratio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-gBRCAmut cohort.”

He added: “Ovarian cancer is the eighth most common cancer in women worldwide.

“Despite high response rates to first-line platinum-based chemotherapy, approximately 85% of patients will experience disease recurrence.

“Once the disease recurs, it is rarely curable, with decreasing time intervals for each subsequent recurrence.”

Shares of GSK fell today and fell 4.19% or 58.96p to 1,349.24p this afternoon, after falling more than 15% last year.



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