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. 

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

Best of ASCO® Spokane June 22, 2018

Earn up to 7.0 Contact Hours & Maintenance of Certification Points

The Association of Community Cancer Centers, Seattle Cancer Care Alliance, and Washington State Medical Oncology Society (WSMOS) are co-presenting highlights from the ASCO Annual Meeting through its licensed Best of ASCO® Meeting on Friday June 22, 6:30 AM – 4:00 PM in Spokane, Washington.

Discover practice-changing scientific and educational updates which reflect the foremost research and strategies in oncology that will directly impact patient care. You’ll engage in interactive sessions led by esteemed speakers—some of the nation's leading cancer care experts—as they share advances in state-of-the-art research and explore how these breakthroughs may impact your practice. 

Whether you were unable to attend the ASCO Annual Meeting in Chicago or are looking to network with renowned oncology researchers and thought leaders, you won't want to miss the exciting educational and collaborative opportunities this local meeting has to offer. Topics to include numerous cancer types, central nervous system tumors, biosimilars, supportive care, quality and care improvement/healthcare delivery, and more! Register for these must-attend sessions today.

VIEW THE AGENDA

This educational activity is jointly provided by AXIS Medical Education and ACCC—and is CME/CPE/CNE-certified for up to 7.0 contact hours. Meeting attendees are now able to earn Maintenance of Certification (MOC) points from the American Board of Internal Medicine (ABIM).

REGISTER TODAY

Discounted Hotel Rates. Best of ASCO attendees can take advantage of a 15% discount on hotel rates at three Marriott properties in Spokane. Click here to access reduced hotel rates at The Historic Davenport, The Davenport Tower, and The Davenport Grand.

Who Should Attend? Multidisciplinary clinical cancer care team members including—but not limited to—medical, surgical, and radiation oncologists; fellows; gastroenterologists; nephrologists; neurologists; oncology nurse practitioners and oncology nurses; pathologists; pharmacists; physician assistants; pulmonologists; radiologists; researchers; oncology nurse practitioners and oncology nurses; pharmacists; physician assistants; and other allied health care professionals.

Program or registration questions? Contact ACCC at 301.984.9496, ext. 200 or via email.

Please forward this email to all members of your cancer care team who would benefit from attending this one-day conference—conveniently located to where you live!

I look forward to seeing you in Spokane!

Sincerely,

Jennie R. Crews, MD, MMM, FACP
Medical Director and Medical Director of Research Integration, Seattle Cancer Care Alliance Network; Associate Professor of Medicine, University of Washington

President-Elect, Washington State Medical Oncology Society (WSMOS)