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China approves AstraZeneca's Imfinzi for advanced non-small cell lung cancer

AstraZeneca’s Imfinzi (durvalumab) is set to be made available in China after the country’s National Medical Products Administration (NMPA) decided to authorise the therapy for the treatment of advanced non-small cell lung cancer (NSCLC).

The approval specifically concerns unresectable, Stage 3 forms of the disease in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT)

FDA gives priority review for AstraZeneca’s Imfinzi

The FDA has granted a priority review of AstraZeneca’s cancer treatment drug Imfinzi (durvalumab) for treatment of patients with untreated small cell lung cancer (SCLC), according to the company.

The move comes after positive results of their Phase 3 CASPIAN trial. The results, recently released in The Lancet journal, showed that there was significant and clinically meaningful improvement in survival rates from the drug.

AstraZeneca's Imfinzi triple combo beats chemo in treatment-naive metastatic lung cancer

AstraZeneca has unveiled positive new Phase 3 data for the combination of Imfinzi (durvalumab) and anti-CTLA4 antibody tremelimumab with chemotherapy in treatment-naïve metastatic non-small cell lung cancer (NSCLC), showing that the therapy met its primary endpoint in the trial.

In a study comparing the efficacy of Imfinzi plus one of five standard-of-care platinum-based chemotherapy options versus chemo alone, the aforementioned combo was shown to generate a “statistically significant and clinically meaningful improvement” in progression-free survival.

AstraZeneca's Imfinzi combo tops chemotherapy in treatment-naive advanced lung cancer

AstraZeneca has unveiled new Phase 3 data for its immunotherapy Imfinzi (durvalumab), showing that it achieved its primary endpoint when combined with four cycles of standard-of-care chemotherapy in the treatment of previously-untreated extensive-stage small cell lung cancer.

The findings showed that the Imfinzi combo reduced the risk of death by 27% with a median overall survival (OS) of 13.0 months versus 10.3 months with SoC, consisting of up to six cycles of chemotherapy and optional prophylactic cranial irradiation (PCI).

AstraZeneca's Imfinzi flops in advanced treatment-naive non-small cell lung cancer

New data have emerged illustrating that AstraZeneca’s anti-CTLA4 antibody Imfinzi (durvalumab) failed to meet its primary endpoint when used in combination with tremelimumab in the treatment of previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC), compared to standard-of-care (SoC) platinum-based chemotherapy.

The study was performed in an all-comers population, with a primary analysis of patients with a high tumour mutational burden (TMB), meaning a higher number of mutations in the tumour’s DNA, potentially making it more visible to the immune system.

AstraZeneca's Imfinzi gets orphan drug designation from FDA

AstraZeneca’s cancer immunotherapy Imfinzi has been granted orphan drug status as a treatment for small cell lung cancer (SCLC).

The FDA has granted Imfinzi (Durvalumab) an Orphan Drug Designation (ODD) as a treatment for SCLC which accounts for around 15% of all lung cancer diagnoses.

SCLC is the most aggressive form of lung cancer with only 6% of patients living for more than 5 years. The FDA grants ODDs to drugs which treat diseases which affect fewer than 200,000 people in the United States.

AstraZeneca's Imfinzi meets endpoint at Phase 3 interim analysis in extensive-stage small cell lung cancer

AstraZeneca has lifted the curtain on new Phase 3 data for Imfinzi (durvalumab) in the first-line treatment of extensive-stage small cell lung cancer (SCLC), illustrating that the therapy met its primary endpoint in a planned interim analysis carried out by an independent data monitoring committee.

The results of the analysis demonstrated that use of Imfinzi, combined with standard-of-care etoposide and platinum-based chemotherapy in the first-line setting, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared to chemotherapy a

AstraZeneca's Imfinzi to be made available via Cancer Drugs Fund in England

AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) will now be made available to English lung cancer patients on the NHS via the Cancer Drugs Fund, NICE has announced.

It is thought that around 165 patients with locally advanced unresectable non-small-cell lung cancer, who have already received platinum-based chemoradiation, will be eligible to receive the drug, which will be made available immediately, through the first year.

AstraZeneca's Imfinzi immunotherapy combo fails to show benefit in lung cancer

AstraZeneca has revealed that its immunotherapy combo of Imfinzi (durvalumab) and tremelimumab failed to meet its primary endpoint in a recent Phase 3 trial in the treatment of previously untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

The results of the study showed that the combo, as well as Imfinzi alone, did not improve overall survival compared to standard of care chemotherapy in patients whose tumours express PD-L1 on more than 25% of their cancer cells.

AstraZeneca chalks up double Japanese approval in lung and breast cancer

It’s a big step forward for AstraZeneca’s global marketing operations as the company announced that two of its products have received approval in Japan in the treatment of two key cancers.

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