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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Zejula Receives FDA Approval for HRD-Positive Advanced Ovarian Cancer
FDA Approvals, News & Updates
December 2019, Vol 10, No 6
On October 23, 2019, the FDA approved a new indication for the PARP inhibitor niraparib (Zejula; Tesaro) for the treatment of patients with homologous recombination deficiency repair (HRD)-positive advanced ovarian, fallopian tube, or primary peritoneal cancer, after receiving ≥3 chemotherapy regimens.
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FDA Approves Calquence for Adults with CLL or SLL
FDA Approvals, News & Updates
December 2019, Vol 10, No 6
On November 21, 2019, the FDA accelerated the approval of acalabrutinib (Calquence; AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma. This drug was approved 4 months earlier than the FDA PDUFA date.
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Tecentriq Approved with Chemotherapy for First-Line Treatment of Metastatic NSCLC without EGFR or ALK Mutations
FDA Approvals, News & Updates
December 2019, Vol 10, No 6
On December 3, 2019, the FDA approved atezolizumab (Tecentriq; Genentech), in combination with paclitaxel protein-bound (Abraxane) and carboplatin chemotherapy, for the first-line treatment of adults with metastatic nonsquamous non–small-cell lung cancer (NSCLC) that does not harbor EGFR or ALK genomic mutations.
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Ziextenzo Third Biosimilar to Neulasta Approved for Febrile Neutropenia
FDA Approvals, News & Updates
,
Biosimilars
December 2019, Vol 10, No 6
On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz) as a third biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor. The previous 2 biosimilars to Neulasta were approved in 2018.
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Brukinsa Receives Accelerated FDA Approval for Mantle-Cell Lymphoma
FDA Approvals, News & Updates
December 2019, Vol 10, No 6
On November 14, 2019, the FDA granted accelerated approval to zanubrutinib capsules (Brukinsa; BeiGene), a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of adults with mantle-cell lymphoma who have received at least 1 previous therapy.
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FDA Will Require Early Assessment of New Targeted Agents That May Be Used in Pediatric Cancers
In the News
,
Pediatric Cancer
Web Exclusives
On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.
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Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma
By
Yvette Florio Lane
FDA Approvals, News & Updates
,
In the News
,
Synovial Sarcoma
Web Exclusives
On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug Designation to the agent for the treatment of soft tissue sarcomas.
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FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
By
Yvette Florio Lane
Bladder Cancer
,
FDA Approvals, News & Updates
,
Immunotherapy
Web Exclusives
On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda).
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November 25, 2019 – Oncology News & Updates
By
Yvette Florio Lane
FDA Approvals, News & Updates
,
In the News
,
Leukemia
,
Lung Cancer
,
Lymphoma
Web Exclusives
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In This Article
Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer
November 18, 2019 — Oncology News & Updates
By
Yvette Florio Lane
FDA Approvals, News & Updates
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Hepatocellular Carcinoma
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In the News
,
Lymphoma
Web Exclusives
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Home
Issues
Online First
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Personalized Medicine
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