Industry News

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 Pemetrexed for Metastatic NSCLC
On January 31, the U.S. Food and Drug Administration (FDA) approved pemetrexed for injection (Alimta, Eli Lilly and Company) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

Read the Eli Lilly and Company press release here.

Posted 1/31/2019

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 Olaparib for Ovarian, Fallopian, Peritoneal Cancers

On December 19, the Food and Drug Administration approved olaparib (Lynparza, 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. Patients with gBRCAm advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.

Read the FDA press release here.

Posted 12/19/2018

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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