Industry News

NCCN Updates Colorectal Cancer Guidelines to Include Braftovi and Mektovi
On March 18, Array BioPharma Inc. announced that the National Comprehensive Cancer Network has updated their Clinical Practice Guidelines to include Braftovi (encorafenib) in combination with Mektovi (binimetinib) and an anti-EGFR antibody as a Category 2a treatment for patients with BRAF-mutant metastatic colorectal cancer (mCRC) after failure of one or two prior lines of therapy for metastatic disease.

Read the Array press release here.

Posted 3/26/2019

FDA Approves Atezolizumab for Small Cell Lung Cancer
On March 19, the FDA approved atezolizumab (Tecentriq^®, Genentech) in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Read the Roche press release here.
Read the FDA press release here.
Download the Tecentriq ES-SCLC Day 1 Letter here.

Posted 3/19/2019

FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin
On March 11, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera^™), a biosimilar to Herceptin, for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Read the Pfizer press release here.

Posted 3/12/2019

FDA Approves Atezolizumab Plus Nab-paclitaxel for TNBC
On March 8, the FDA approved atezolizumab (Tecentriq, Genentech Inc.) plus nab-paclitaxel (Abraxane, Celgene) for the frontline treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC).

Read OncLive news coverage here.

Posted 3/8/2019

FDA Approves Trastuzumab and Hyaluronidase-oysk for Breast Cancer
On February 28, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech Inc.) for the treatment of HER2-overexpressing breast cancer.

FDA Approves Trifluridine and Tipiracil for Gastric/GEJ Adenocarcinoma
On February 25, the U.S. Food and Drug Administration approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) for the treatment of 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.

Read the Taiho Oncology press release here.

Posted 2/25/2019

FDA Approves Pembrolizumab for Melanoma
On February 15, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Read the FDA press release here.

Posted 2/19/2019

FDA Approves Ibrutinib Plus Obinutuzumab for CLL/SLL
On January 28, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Read the Janssen press release here.

Posted January 28, 2019

Medicare Coverage Established for MRD Testing for ALL, Multiple Myeloma
On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing.

Read the Adaptive Biotechnologies press release here.

Posted 1/23/2019

FDA Approves Pembrolizumab for Merkel Cell Carcinoma

On December 19, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Read the FDA press release here.

Posted 12/19/2018

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