AstraZeneca plc., is a global, innovation-driven biopharma major formed through the merger of Swedish Astra AB and British Zeneca Group Plc in 1999.
- In Dec 2020, the US FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (ENHERTU®, AstraZeneca and Daiichi Sankyo) for patients with unresistible or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
- In April 2020, the US FDA approved KOSELUGO (Selumetinib) for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Selumetinib, a kinase inhibitor, is the first therapy approved for pediatric patients who have this debilitating, and often disfiguring, rare disease.
- In Nov 2019, US FDA approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Earlier in Oct 2017, the U.S. FDA granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
- In Sep 2018, US FDA approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti comprises the CD22 binding portion of an antibody fused to a truncated bacterial toxin; the toxin inhibits protein synthesis and ultimately triggers apoptotic cell death.
- In May 2017, the US FDA granted accelerated approval to IMFINZI (durvalumab) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months. In 2019, IMFINZI is also approved in adults with unresistible, Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
- In Nov 2015, the FDA approved Tagrisso (Osimertinib) to treat non-small-cell lung carcinomas, if the cancer cells are positive for the T790M mutation in the gene coding for EGFR or for activating EGFR mutations. Osimertinib is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor.
- In July 2015, the FDA approved Gefitinib as a first-line treatment for NSCLC.
- In Dec 2014, Lynparza (Olaparib), an oral poly ADP-ribose polymerase (PARP) inhibitor was approved in the EU for the treatment of adult patients with platinum-sensitive relapsed BRCA-mutated epithelial ovarian, fallopian tube or primary peritoneal cancer. It was approved in the US for the treatment of patients with germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
- Lynparza (Olaparib) was further approved for certain types of breast cancer, BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma and metastatic castration-resistant prostate cancer.
- In Apr 2011, Vandetanib/Caprelsa became the first drug to be approved by the FDA for late-stage medullary thyroid cancer.
- In May 2003, Gefitinib/Iressa® was approved by the FDA as monotherapy for the treatment of non-small cell lung cancer. Astrazeneca is currently marketing Gefitinib/Iressa® in collaboration with Teva Pharmaceuticals.
- In Apr 2002, FDA approved Fulvestrant/Faslodex® for the treatment of hormone receptor-positive metastatic breast cancer.
- In Jan 1996, Anastrozole/Arimidex® was approved by FDA for treatment of advanced breast cancer in postmenopausal women.
- In Oct 1995, Bicalutamide/Casodex® was approved by FDA as a combination therapy with a LHRH analog for prostate cancer.
- In Dec 1989, Goserelin acetate implant/Zoladex® was approved by US FDA for the treatment of advanced prostate cancer and in late 1995, for the treatment of breast cancer.
- In 1977, Nolvadex/Tamoxifen® was approved by the US FDA as hormonal therapy for the treatment of metastatic breast cancer.
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