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 

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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

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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. 

New FDA Approval for Avastin® (bevacizumab)

Genentech's Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. 

Full Genentech Announcement Letter

Prescribing Information

New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in PMBCL.

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information. The Medication Guide also is available.

Click Here to read the Merck Press Release