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Issues
2019
April 2019, Vol 10, No 2
April 2019, Vol 10, No 2
Lonsurf Approved for Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On February 22, 2019, the FDA approved a new indication for trifluridine plus tipiracil (Lonsurf; Taiho Pharmaceuticals), an oral combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor for the treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma who received ≥2 lines of chemotherapy regimens with a fluoropyrimidine, a platinum, a taxane or irinotecan, and, if appropriate, HER2/
neu
-targeted therapy. The FDA used its priority review process for this new indication and granted it an orphan drug designation. Trifluridine plus tipiracil was previously approved for metastatic colorectal cancer.
Read Article
Keytruda Approved for Adjuvant Treatment for Patients with Melanoma
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On February 15, 2019, the FDA approved pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with melanoma and involvement of lymph node(s) after a complete resection. This is the second melanoma-related indication for pembrolizumab, which was previously approved by the FDA for the treatment of patients with unresectable or metastatic melanoma.
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Keytruda plus Alimta Combination Approved for First-Line Therapy of Metastatic NSCLC
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On January 31, 2019, the FDA approved the combination of pemetrexed (Alimta; Eli Lilly) plus pembrolizumab (Keytruda; Merck) and platinum-based chemotherapy for first-line treatment of patients with metastatic nonsquamous non–small-cell lung cancer (NSCLC) and no
EGFR
or
ALK
mutations.
Read Article
Imbruvica plus Gazyva Approved as First-Line Treatment for CLL/SLL
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On January 28, 2019, the FDA approved the combination of the oral Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica; Pharmacyclics), plus the CD20-directed cytolytic antibody obinutuzumab (Gazyva; Genentech), for the treatment of adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Imbruvica was already approved as a single agent for different indications, including for adults with CLL or SLL, with or without 17p deletion.
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Cabometyx Now Indicated for Hepatocellular Carcinoma
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On January 14, 2019, the FDA approved a new indication for cabozantinib (Cabometyx; Exelixis), an oral multitargeted tyrosine kinase inhibitor, for the treatment of patients with hepatocellular carcinoma who had previously received treatment with sorafenib (Nexavar).
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Personalizing Immunotherapy in NSCLC Using PD-L1 and Tumor Mutation Burden as Biomarkers
By
Wayne Kuznar
Immunotherapy
,
Lung Cancer
,
Solid Tumors
,
Personalized Medicine
April 2019, Vol 10, No 2
San Francisco, CA—Tumor expression of PD-L1 has consistently predicted response and survival outcomes in non–small-cell lung cancer (NSCLC), whereas the role of PD-L1 in immune cells is unclear, said Edward B. Garon, MD, Director, Thoracic Oncology Program, David Geffen School of Medicine, University of California, Los Angeles, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium.
Read Article
CAR T-Cell Therapy Fills Unmet Needs in Leukemia and Lymphoma
By
Wayne Kuznar
Immunotherapy
,
Leukemia
,
Lymphoma
,
Hematologic Malignancies
,
Personalized Medicine
April 2019, Vol 10, No 2
San Francisco, CA—Many patients with leukemia or lymphoma who receive treatment with anti-CD19 chimeric antigen receptor (CAR) T-cell therapy achieve minimum residual disease (MRD) negativity, and many are in complete remission well beyond 12 months.
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Atezolizumab plus Nab-Paclitaxel for Triple-Negative Breast Cancer with PD-L1 Expression
By
Phoebe Starr
Breast Cancer
April 2019, Vol 10, No 2
San Antonio, TX—Adding the PD-L1 inhibitor atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) chemotherapy is the first immunotherapy-based combination to improve progression-free survival (PFS) and overall survival (OS) in women with advanced or metastatic triple-negative breast cancer and PD-L1 expression compared with placebo plus nab-paclitaxel, according to results of the IMpassion130 clinical trial.
Read Article
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Home
Issues
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