Practice InformationThe following section is additional information posted from our Corporate members to supplement product announcements.
- Astellas Pharma US, Inc. is pleased to announce that the FDA has approved XOSPATA. XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. Click here for more. Click here for safety information. Click here for prescribing information.
- Gennetech – The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). Click here for more.
- Genentech announced the FDA granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low dose cytarabine (LDAC), for the treatment of people with newly-diagnosed acute myeloid leukemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. The Genentech press release including Important Safety Information is linked here. Click here for prescribing information.
- Seattle Genetics – On November 16, 2018, the U.S. Food and Drug Administration (FDA) approved a label change for ADCETRIS® (brentuximab vedotin) for injection, for intravenous use.
- Osimertinib (TAGRISSO®) is now the only preferred first-line EGFR TKI in the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®)
- FDA-Approved Indication for KEYTRUDA® (pembrolizumab) in Combination With Carboplatin and Either Paclitaxel or Nab-paclitaxel for the First-line Treatment of Patients With Metastatic Squamous Non–Small Cell Lung Cancer (NSCLC) Merck is pleased to announce that KEYTRUDA in combination with carboplatin and either paclitaxel or nab-paclitaxel has been approved by the FDA for the first-line treatment of patients with metastatic squamous NSCLC.
- AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
- From Pfizer –FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer, for prescribing information, click here.
- U.S. Fda Approves Vizimpro® (Dacomitinib) For The First-Line Treatment Of Patients With Egfr-Mutated Metastatic Non-Small Cell Lung Cancer For prescribing information, click here.
- AstraZeneca presented the results from the Phase III PACIFIC clinical trial at the World Conference on Lung Cancer, showing that IMFINZI® (durvalumab) reduced the risk of death by 32% compared to placebo (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025)
- Pharmacyclics LLC, an AbbVie Company, announces the new FDA approval for the expanded use of IMBRUVICA® (ibrutinib),
- AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk),
- FDA Approves Expanded Label for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy for First-Line Treatment of Patients with Metastatic Nonsquamous NSCLC, with No EGFR or ALK Genomic Tumor Aberrations
- XTANDI significantly extended metastasis-free survival* in patients with nonmetastatic CRPC1
- NIVESTYM™, a biosimilar to Neupogen ® (filgrastim), is Pfizer’s fourth biosimilar to be approved by the FDA
- Array BioPharma Inc. is pleased to announce the FDA approval of BRAFTOVI and MEKTOVI.
- KEYTRUDA® Prescribing Information and Medication Guide
- Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent,is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
- Avastin Prescribing Information
- Sample Billing Codes for VENCLEXTA
- Venclexta Prescribing Information