> The FDA on October 17, 2012 expanded the labeling for ALIMTA® to include the results of an additional trial evaluating the safety and efficacy of ALIMTA®) for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer followed by pemetrexed maintenance in patients whose disease has not progressed after four cycles of platinum and pemetrexed as first-line chemotherapy. ALIMTA® is a product of Eli Lilly and Company.
Author: RR
ABRAXANE® (Paclitaxel albumin-bound particles)
The FDA on October 11, 2012 approved ABRAXANE® (Paclitaxel albumin-bound particles) for use in combination with PARAPLATIN® (Carboplatin) for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for curative surgery or radiation therapy. ABRAXANE® is an injectable suspension and is a product of Celgene Corporation.
STIVARGA® (Regorafenib)
The FDA on September 27, 2012 approved STIVARGA® (Regorafenib) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, ELOXATIN® (Oxaliplatin)-, and CAMPTOSAR® (Irinotecan)-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. STIVARGA® tablets are a product of Bayer HealthCare Pharmaceuticals, Inc.
BOSULIF® (Bosutinib)
The FDA on September 4, 2012 approved BOSULIF® (Bosutinib) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy. BOSULIF® tablets are a product of Pfizer, Inc.
XTANDI® (Enzalutamide)
The FDA on August 31, 2012 approved XTANDI® (Enzalutamide) for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI® capsules are a product of Medivation, Inc. and Astellas Pharma US, Inc.
AFINITOR® (Everolimus)
The FDA on August 30, 2012 granted accelerated approval for AFINITOR® (Everolimus) for the treatment of pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. AFINITOR® tablets for oral suspension (AFINITOR® Disperz) is a product of Novartis Pharmaceuticals Corp.
MARQIBO® (vinCRIStine sulfate LIPOSOME injection)
The FDA on August 9, 2012 granted accelerated approval for MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. MARQIBO® is a product of Talon Therapeutics, Inc.
ZALTRAP® (Ziv-aflibercept injection)
The FDA on August 3, 2012 approved ZALTRAP® (Ziv-aflibercept injection), for use in combination with 5-fluorouracil, leucovorin, CAMPTOSAR® (Irinotecan) (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin containing regimen. ZALTRAP® is a product of Sanofi U.S., Inc.
PX-171-003-A1, an open-label, single-arm, phase (Ph) II study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (R/R MM) Long-term follow-up and subgroup analysis
SUMMARY: KYPROLIS® (Carfilzomib) is a second generation proteasome inhibitor. Unlike VELCADE® (Bortezomib), proteasome inhibition with KYPROLIS® is irreversible. The approval of KYPROLIS® was based on a phase 2b, single-arm, multicenter clinical study in which 266 patients with advanced refractory Multiple Myeloma who had progressed on 2 or more prior therapies were evaluated. Prior therapies included treatment with VELCADE® (Bortezomib), REVLIMID® (Lenalidomide) or THALOMID® (Thalidomide). The primary end point was Overall Response Rate (ORR). The ORR with single agent KYPROLIS® was 24%, with a median duration of response of 7.4 months. This benefit was seen regardless of unfavorable cytogenetics. Peripheral neuropathy was infrequent and the most common adverse events were primarily hematologic. Patients with resistant and refractory Multiple Myeloma now have a new treatment option after a six year hiatus. Siegel DSD, Martin T, Wang M, et al. J Clin Oncol 29: 2011 (suppl; abstr 8027)
FDA approves STIVARGA® (Regorafenib) for Advanced Colorectal Cancer
SUMMARY: The FDA approved STIVARGA® (Regorafenib), an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer (CRC) who have progressed on 5FU, ELOXATIN® (Oxaliplatin), CAMPTOSAR® (Irinotecan), anti- VEGF and anti-EGFR therapies. The approval was based on a phase III trial in which 760 patients with metastatic CRC who had progressed after approved standard therapies, were randomly assigned in a 2:1 ratio to receive either STIVARGA® plus best supportive care (BSC) or placebo plus BSC. Patients receiving STIVARGA® had a statistically significant improvement in the overall survival and progression free survival compared to placebo, without any unexpected toxicities. The most common side effects of STIVARGA® were fatigue, loss of appetite, hand-foot syndrome, diarrhea, mucositis, elevated blood pressure, and dysphonia. This important study gives a new option for individuals with advanced colorectal cancer. Grothey A, F. Sobrero AF, Siena S, et al. J Clin Oncol 30, 2012 (suppl 4; abstr LBA385)