Industry News

FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma
On April 19, the FDA approved pembrolizumab (Keytruda, Merck & Co. Inc.) plus axitinib (Inlyta, Pfizer Inc.) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Read the full FDA press release here.

Posted 4/22/2019

FDA Approves Erdafitinib for Metastatic Urothelial Carcinoma
On April 12, the Food and Drug Administration granted accelerated approval to erdafitinib (Balversa, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication.

Read the full FDA press release here.

Posted 4/12/2019

FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment
On April 11, 2019, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.

Read the FDA press release here.

Posted 4/12/2019

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

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

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.

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