New FDA Approval for BLINCYTO®

On March 29th, 2018 the U.S. Food and Drug Administration (FDA) granted approval to BLINCYTO® (blinatumomab) for the treatment of minimal residual disease (MRD)-positive B-cell precursor Acute Lymphoblastic Leukemia (ALL).  

The FDA approved Amgen’s supplemental Biologics License Application (sBLA) for BLINCYTO® based results from the BLAST study.  

For additional information on the approval, please click here to access the full Amgen press release. 

Please see below for the Indications and Important Safety Information for BLINCYTO®.

Complete information regarding dosing and administration, warnings, precautions, safety and efficacy, can be found in the full prescribing information by clicking here.

New FDA Approval for IMBRUVICA®

On August 27, 2018 – AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). With this approval, the IMBRUVICA prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. IMBRUVICA was first approved as a single agent therapy for WM in January 2015. IMBRUVICA is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

Read the Press Release

Click here to access the complete, updated Prescribing Information

FDA Approval for VIZIMPRO®

On September 27, 2018 Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved  VIZIMPRO®  [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. 

See the full Prescribing Information

 Read the Press Release

FDA Approves Expanded Label for Merck’s KEYTRUDA®

On August 20, 2018, Merck press release announces: 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 

Approval Based on Results of KEYNOTE-189, Where KEYTRUDA in Combination with Pemetrexed and Platinum Chemotherapy Reduced the Risk of Death by Half Compared to Chemotherapy Alone 

Prescribing Information 

Read the Press Release

Medication Guide

New FDA Approval for Opdivo® (nivolumab)

August 17, 2018 - U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer 

  • Opdivo is now the first Immuno-Oncology treatment approved for small cell lung cancer (SCLC) patients who received platinum-based chemotherapy and at least one other line of therapy
  • Approval based on overall response rate and duration of response from the SCLC cohort of the Phase 1/2 CheckMate -032 trial 

Click Here to read the Press Release from Bristol-Myers Squibb

New FDA Approval for Merck's KEYTRUDA®

June 12, 2018 – Merck  announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®  the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (C

FDA Approves Pfizer's NIVESTYM™ (filgrastim-aafi)

On July 20, 2018, Pfizer announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.

“The FDA approval of NIVESTYM marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy,” said Berk Gurdogan, U.S. Institutions President, Pfizer Essential Health. “We believe biosimilars, like NIVESTYM, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”

The FDA approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NIVESTYM compared to its reference product.

Click Here to read the entire Press Release

Click Here for Prescribing Information

Gilotrif® dose adjustments reduce the frequency and intensity of adverse drug reactions without impacting efficacy

On May 31, 2018 – Boehringer Ingelheim announced results from a retrospective, observational real-world study assessing the impact of dose adjustments of Gilotrif® (afatinib) on safety and efficacy in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC). The study showed that dose adjustment with Gilotrif helped improve patient tolerability while maintaining treatment efficacy and reduced the frequency and intensity of drug reactions. These findings, which were consistent with clinical trials, were published online by the American Society of Clinical Oncology (ASCO) in advance of its 2018 annual conference. 

Click Here to read the full announcement.