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, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. FDA approved glasdegib (DAURISMO, Pfizer Labs) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.
FDA granted regular approvals to dabrafenib and trametinib (TAFINLAR and MEKINIST, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. FDA approved givosiran (GIVLAARI, Alnylam Pharmaceuticals, Inc.) for adults with acute hepatic porphyria (AHP).
FDA granted marketing approval to the Praxis Extended RAS Panel (Illumina, Inc.), a next generation sequencing (NGS) test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer (mCRC). FDA approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
All Rights Reserved. FDA approved trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
FDA granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
FDA approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. FDA granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
FDA approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.
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FDA approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
Food and Drug Administration approved avapritinib (AYVAKIT, Blueprint Medicines Corporation) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations. FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. More Information. FDA granted regular approval to axicabtagene ciloleucel (YESCARTA, Kite Pharma, Inc.) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
FDA approved niraparib (ZEJULA, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. Alcon. Media Releases.
The mission of Novartis in the field of ophthalmology is to discover, develop and manufacture innovative products to improve eye health and enhance people’s lives. FDA granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited) for the 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 of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. You’ll have access to the site in a moment, or click continue to close this message and advance directly to the site.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA. If you do not wish to leave this site, click Cancel. FDA granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
FDA granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.
May 8, 2020. More Information. January 23, 2020, FDA approved cabozantinib (CABOMETYX, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Before sharing sensitive information, make sure you're on a federal government site.
FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. FDA granted accelerated approval to acalabrutinib (Calquence, AstraZeneca Pharmaceuticals Inc. under license of Acerta Pharma BV) for treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
FDA approved cemiplimab-rwlc (LIBTAYO, Regeneron Pharmaceuticals Inc.) for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. FDA updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. April 17, 2020, Food and Drug Administration approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC).
FDA expanded the indication for ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. FDA granted accelerated approval to entrectinib (ROZLYTREK, Genentech Inc.) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. Food and Drug Administration approved azacitidine tablets (ONUREG, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. More Information.
April 3, 2020, Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
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