Industry News

FDA Expands Palbociclib Use to Include Male Breast Cancer Patients
On April 4, the U.S. Food and Drug Administration extended the indication of palbociclib (Ibrance, Pfizer Inc.) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

Read the full FDA press release here.

Posted 4/5/2019

HCPCS Assigns J-Code and ASP for Imfinzi

Imfinzi (durvalumab) has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and average sales price (ASP) by the Centers for Medicare & Medicaide Services (CMS). The following code can be used to identify Imfinzi when billing across settings of care:
- J9173: Injection, durvalumab, 10 mg (vial size 500mg/10 mL, billing unit 50 units, NDC 0310-4611-50)
- J9173: Injection, durvalumab, 10 mg (vial size 120mg/2.4 mL, billing unit 12 units, NDC 0310-4500-12)
Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of this information does not guarantee reimbursement. Healthcare providers are encouraged to contact payers to confirm code adoption and approved usage prior to submitting claims. Imfinzi is listed in the April 2019 ASP Pricing File:
- J9173: Inj., durvalumab, 10 mg (HCPCS code dosage 10MG, payment limit $73.778).
Posted 12/19/2018

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

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