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Tag Archives: AstraZeneca

Guardant360 CDx OK’d as companion diagnostic for Enhertu

Aug. 23, 2022–Guardant Health announced that the FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic to select patients with unresectable or metastatic HER2 (ERBB2)-mutant non-small cell lung cancer whose tumors have activating HER2 mutations (single nucleotide variants and exon 20 insertions) for treatment with Enhertu

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FDA approves Enhertu for breast cancer

May 18, 2022—Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the United States for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

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FDA approves new indication for Tagrisso

Dec. 23, 2020—AstraZeneca’s Tagrisso (osimertinib) has been FDA approved for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after tumor resection with curative intent.

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FDA expands approval of olaparib

February 2019—Olaparib (Lynparza, AstraZeneca) has been approved by the FDA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy.

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FDA OKs Imfinzi for unresectable stage III NSCLC

March 13, 2018—AstraZeneca and MedImmune, its biologics research and development arm, announced the FDA has approved Imfinzi (durvalumab) for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. “This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the ...

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