Updated VELCADE Label Announced
On January 4, 2010 Millennium announced that the FDA has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term overall survival data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. the VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM). Click Here to read the press release, Click Here to read the Physician Announcement Letter
Lilly Announces New Alimata Indication
On July 6, 2009, the US Food and Drug Administration (FDA) approved an additional indication for ALIMTA® (pemetrexed for injection) (HCPCS code J9305). Now, ALIMTA is indicated for the maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Click Here to read the announcement letter to WSMOS from Lilly.
Click Here to access the updated ALIMTA package insert.
Updated Abraxane Monograph in DrugDex
On February 4, 2009 DrugDex updated its Abraxane monograph to include first-line combination treatment of NSCLC. The language from the DrugDex monograph appears below.
4.5.E Non-small cell lung cancer, Advanced or metastatic, first-line treatment, in combination with carboplatin and bevacizumab
1) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference: RECOMMENDATION AND EVIDENCE RATINGS
2) Summary:
In an open-label, phase 2 study presented in abstract form and as a presentation (n=50), 31.3% of patients with advanced non-small-cell lung cancer (NSCLC) achieved a partial response following first-line therapy with nanoparticle albumin-bound paclitaxel, carboplatin, and bevacizumab.(Reynolds et al, 2007; Reynoldset al,null).
Copies of the updated Abraxane monograph are available at Abraxis Oncology’s ARC of Support – that number is (800) 564-0216, Option 3. Representatives are available from 8 AM to 8 PM, Monday to Friday.
Novartis Announces Afinitor® Approved for Advanced Renal Cell Carcinoma
Novartis Pharmaceuticals Corporation is pleased to announce the introduction of Afinitor® (everolimus) tablets, approved by the FDA on March 30, 2009. Afinitor® is a once daily oral mTOR inhibitor indicated for the treatment of advanced Renal Cell Carcinoma (RCC). Afinitor® is available by prescription only and package in a blister card.
More information:
Click Here for the Letter to Wholesalers
Click Here for Pharmacy Ordering Instructions
Click Here for the Labeling Revised 03/2009
Allos Therapeutices Announces FDA Approval of FOLOTYN™
FOLOTYN™ (pralatrexate injection) has received FDA approval for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. More information is available at www.allos.com.
