Packaging/Label Updates

To submit packaging updates for posting consideration, forward to info@nnecos.org.

FDA updates prescribing information for Keytruda and Tecentriq

On August 16, 2018, the Food and Drug Administration updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617378.htm



Label Change for Tasigna
FDA updated the product label for nilotinib (Tasigna, Novartis Pharmaceuticals Corp.) to include information on nilotinib discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have achieved a sustained molecular response (MR 4.5). More Information. December 22, 2017


Label Change for ADCETRIS

On November 9, 2017, the Food and Drug Administration (FDA) approved a label change for ADCETRIS (brentuximab vedotin) for injection, for intravenous use. Attached is a copy of the updated US Prescribing Information (USPI) for your review. Our new indication is as follows: · Treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Please see Important Safety Information, including BOXED WARNING, below and full Prescribing Information at adcetrispro.com

Package Update for lenalidomide

Celgene Corporation is pleased to announce the new approval for the use of REVLIMID® (lenalidomide) as maintenance therapy for MM patients after autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated as maintenance therapy in patients with multiple myeloma (MM) following autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
Please see full Prescribing Information, including Boxed Warnings.

New survival data on enzalutamide

Extended survival and improved radiographic progression-free survival data from PREVAIL and TERRAIN trials. Read more at https://eorder.sheridan.com/3_0/app/orders/6242/article.php

U.S. FDA Modifies Erlotinib Indication

FDA modified the indication for erlotinib (TARCEVA, Astellas Pharm Global Development Inc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.  October 18, 2016.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm525739.htm

U.S. FDA Expands IMBRUVICA® (ibrutinib) Label to Include Overall Survival Data

U.S. FDA Expands IMBRUVICA® (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL), New Indication for Small Lymphocytic Lymphoma (SLL) Patients and Combination Dosing IMBRUVICA® with Bendamustine and Rituximab (BR) for CLL/SLL patients.


FDA modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer.  The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks.  September 13, 2016. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm520871.htm


IMBRUVICA® (ibrutinib) is now approved for all lines of CLL therapy, with no chemotherapy required.1 The latest approval of IMBRUVICA® for frontline CLL is based on results from the pivotal RESONATE™-2 trial.1

The National Comprehensive Cancer Network® (NCCN®) has also updated its recommendations for CLL therapy. Ibrutinib is the only chemo-free single agent with Category 1 NCCN recommendations for frontline and R/R CLL without del 17p.2

https://www.imbruvicahcp.com/

FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm490329.htm


Pembrolizumab label updated with new clinical trial information

On December 18, 2015, the U. S. Food and Drug Administration (FDA) expanded the label to include the approval of pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp.) for the treatment of patients with unresectable or metastatic melanoma. This expansion now includes the initial treatment of patients with unresectable or metastatic melanoma with pembrolizumab. More information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm478493.htm


FDA Approves Label Update for Pomalyst -Now with Phase 3 Survival Data

Celgene Corporation is pleased to announce that POMALYST (pomalidomide) + low-dose dexamethasone (dex) delivered significantly longer progressin-free survival (PFS) vs high-dose dex in a phase 3 clinical trial.

http://ir.celgene.com/releasedetail.cfm?releaseid=908418


FDA Approves Revlimid for Newly Diagnosed Multiple Myeloma

REVLIMID in combination with dexamethasone now for use in patients with newly diagnosed multiple
myeloma (ndMM)

Celgene Corporation is pleased to announce that the Prescribing Information for REVLIMID now includes safety and efficacy data for REVLIMID in combination with dexamethasone in patients with newly diagnosed multiple myeloma.

http://www.revlimid.com/wp-content/uploads/2013/11/PI.pdf


FDA Approves a New Indication for XTANDI (enzalutamide) capsules

The US Food and Drug Administration (FDA) has approved a new indication for XTANDI, an androgen receptor inhibitor. XTANDI is now indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). Approval of the New Indication Is Based on Efficacy and Safety Results From the PREVAIL Trial PREVAIL was a multinational, double-blind, randomized, phase 3 trial (N=1717) comparing XTANDI + gonadotropin-releasing hormone (GnRH) therapy* (n=872) and placebo + GnRH therapy* (n=845) in chemotherapy-naive patients with metastatic CRPC whose disease had progressed on GnRH therapy.*1-3

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203415s003lbl.pdf

FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma

The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes dosing guidelines as well as safety and efficacy findings for single-agent use or use in in combination with dexamethasone in patients previously treated with bortezomib. Bortezomib retreatment may be started at the last tolerated dose.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s038lbl.pdf

Label Update for Jakafi®

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf

July 28, 2014

U.S. Food & Drug Administration (FDA) has approved supplemental labeling for Jakafi®(ruxolitinib) to include new Kaplan-Meier overall survival curves as well as additional safety and dosing information. The new overall survival information is based on three-year data from the two pivotal Phase III trials, COMFORT-I and II, and shows that at three years the probability of survival for patients treated with Jakafi in COMFORT-I was 70% and for those patients originally randomized to placebo it was 61%. In COMFORT-II, at three years the probability of survival for patients treated with Jakafi was 79% and for patients originally randomized to best available therapy (BAT) it was 59%. The full prescribing information for Jakafi can be found a twww.incyte.com.

FDA Approves Label Change for ADCETRIS

On Aug 19, 2013, the FDA issued a label change for ADCETRIS® (brentuximab vedotin).

Key label changes include:

  1. Dosage and Administration Section 1: 16 cycle limitation has been removed from the label. New label states “Continue treatment until disease progression or unacceptable toxicity”
  2. Warnings and Precautions Section 5: Growth factor support added for consistency with Dose Modification in section 2.2

Complete details available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf




FDA Approves U.S. Product Labeling Update for Sprycel® (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase

Data added to Sprycel U.S. labeling are among the longest follow-up data of current CML treatment options


http://news.bms.com/press-release/rd-news/fda-approves-us-product-labeling-update-sprycel-dasatinib-include-three-year-f



Northern New England Clinical Oncology Society
P.O. Box 643
Sandown, NH 03873-0643
Telephone (603) 887-1948
info@nnecos.org

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