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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Piqray First PI3K Inhibitor Approved by the FDA for Metastatic Breast Cancer and PI3KCA Mutation
FDA Approvals, News & Updates
June 2019, Vol 10, No 3
On May 24, 2019, the FDA approved Piqray (alpelisib; Novartis), an oral PIK3 inhibitor, in combination with endocrine therapy with fulvestrant (Faslodex), for the treatment of postmenopausal women, as well as men, with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer and
PIK3CA
mutation (as detected by an FDA-approved test) that progressed during or after an endocrine-based treatment regimen. The FDA used its priority review designation to consider the application of alpelisib.
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Kadcyla Approved for Adjuvant Treatment of HER2-Positive Early Breast Cancer with Residual Invasive Disease
FDA Approvals, News & Updates
June 2019, Vol 10, No 3
On May 3, 2019, the FDA approved a new indication for ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab (Herceptin)-based treatment. The FDA granted this application priority review.
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Tibsovo Now Indicated for First-Line Treatment of Patients with AML and IDH1 Mutation
FDA Approvals, News & Updates
June 2019, Vol 10, No 3
On May 2, 2019, the FDA approved ivosidenib (Tibsovo; Agios) for patients with newly diagnosed acute myeloid leukemia (AML) and a susceptible
IDH1
mutation, as detected by an FDA-approved test, in patients aged ≥75 years or those who have comorbidities that preclude the use of intensive induction chemotherapy. Ivosidenib was originally approved in 2018 for relapsed or refractory AML with
IDH1
mutation.
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Keytruda plus Inlyta New First-Line Combination Approved for Advanced Renal-Cell Carcinoma
FDA Approvals, News & Updates
June 2019, Vol 10, No 3
On April 19, 2019, the FDA accelerated the approval of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) as first-line treatment of patients with advanced renal-cell carcinoma (RCC). Keytruda was previously approved as a single agent or in combination with other agents for many other indications and types of cancers.
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Balversa First Targeted Drug FDA Approved for Metastatic Bladder Cancer with FGFR Genetic Alterations
FDA Approvals, News & Updates
June 2019, Vol 10, No 3
On April 12, 2019, the FDA accelerated the approval of erdafitinib (Balversa; Janssen), a fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with locally advanced or metastatic urothelial carcinoma and a susceptible
FGFR3
or
FGFR2
genetic alteration, as detected by an FDA-approved test, whose disease progressed after platinum-containing chemotherapy, making it the first targeted drug to receive approval for this patient population.
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First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
By
Yvette Florio Lane
FDA Approvals, News & Updates
,
In the News
Web Exclusives
On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation.
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FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
Breast Cancer
,
FDA Approvals, News & Updates
,
In the News
,
Personalized Medicine
,
Solid Tumors
Web Exclusives
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).
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Trazimera Fourth Biosimilar to Herceptin Approved for HER2-Positive Breast Cancer or HER2-Positive Metastatic Gastric or Gastroesophageal Junction Cancer
Breast Cancer
,
FDA Approvals, News & Updates
,
Biosimilars
April 2019, Vol 10, No 2
On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin.
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Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On March 18, 2019, atezolizumab (Tecentriq; Genentech) received a new indication for use with carboplatin and etoposide chemotherapy as first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC).
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Tecentriq plus Abraxane for Advanced or Metastatic Triple-Negative Breast Cancer with PD-L1 Expression
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC.
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