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
Read More »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.
Read More »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.
Read More »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.
Read More »FDA OKs Imfinzi for unresectable stage III NSCLC, 5/18
May 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.
Read More »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 ...
Read More »AstraZeneca collaborations, 10/14
October 2014—AstraZeneca announced it has entered into a collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small cell lung cancer.
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