U.S. Food And Drug Administration Approves Pfizer’s INLYTA® (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)
The U.S. Food and Drug Administration (FDA) has approved INLYTA® (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. The approval is based on data from the Phase 3 AXIS trial, which demonstrated that INLYTA significantly extended progression free survival (PFS) [HR=0.67, 0.54-0.81, P<0.0001] with a median PFS of 6.7 months (95% CI: 6.3, 8.6) compared with 4.7 months (95% CI: 4.6, 5.6) for those treated with sorafenib, a current standard of care for this patient population, representing a 43 percent improvement in median PFS compared to sorafenib. For more information and full prescribing information please visit www.InlytaHCP.com.
New Route of Administration for Millenium's VELCADE (bortezomib)
The U.S. Food and Drug Administration (FDA) has approved VELCADE for subcutaneous administration in patients with multiple myeloma (MM) and relapsed mantle cell lymphoma (MCL).
- Coding for subcutaneous administration: The J code for VELCADE is J9041. The service code for subcutaneous administration of VELCADE will generally be 96401. Please visit VELCADEHCP.com for additional information.
- Reconstitution of VELCADE for subcutaneous administration is different from IV Coding for subcutaneous administration The reconstituted concentration of VELCADE for subcutaneous administration (2.5 mg/mL) is greater than the reconstituted concentration for IV administration (1 mg/mL).
- Update to Contraindications: The updated label also includes a contraindication for intrathecal administration as fatal events have occurred with the inadvertent intrathecal administration of VELCADE. VELCADE is for intravenous or subcutaneous use only.
FDA Approves two new indications for Amgen's Prolia® (denosumab)
The U.S. Food and Drug Administration (FDA) has approved the following new indications:
Seattle Genetics Announces FDA Accelerated Approval of ADCETRIS™
(Brentuximab Vedotin) for Two Indications
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of ADCETRISTM (brentuximab vedotin) for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate.
FDA Approves Pfizer’s XALKORI® (crizotinib) As First And Only Therapy Specifically For Patients With Locally Advanced Or Metastatic ALK-Positive Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved XALKORI® (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test. The effectiveness of XALKORI is based on objective response rates (ORR) and, as XALKORI received accelerated approval from the FDA.
FDA Approves Centocor Orthobiotech's ZYTIGATM (abiraterone acetate) for late-stage prostate cancer
The U.S. Food and Drug Administration has approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). Training audio conference available.
FDA Approves Celgene's ISTODAX (romidepsin) for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least 1 prior therapy
ISTODAX (romidepsin) for injection has been approved for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least 1 prior therapy. ISTODAX is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least 1 prior systemic therapy.
FDA Approves Genentech's RITUXAN® (Rituximab) for previously untreated follicular, CD20-positive, B-cell NHL
RITUXAN® (Rituximab) has been approved by the FDA for previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy.
FDA Approves Amgen's Xgeva (Denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors
Amgen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Xgeva (denosumab), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6-month priority review by the FDA, a designation reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.
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