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

FDA Approval for Genentech's VENCLEXTA®

On June 8, 2018,  VENCLEXTA® venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

 

Genentech BioOncology® Access Solutions is your resource for access and reimbursement support after VENCLEXTA is prescribed. We can help your patients by providing: 

·       Benefits investigations (BIs)

·       Prior authorization (PA) resources

·       Information about authorized specialty pharmacies (SPs) and specialty distributors 

·       Sample billing and coding information

·       Resources for denials and appeals

·       Patient assistance options

A list of authorized specialty pharmacies and specialty distributors is available at                         Genentech-Access.com/VENCLEXTA.

 

For more information about Genentech BioOncology Access Solutions, please visit Genentech-Access.com/VENCLEXTA or call (888) 249-4918.

Genomic Health Announces TAILORx Study Results

On June 3, 2018, Genomic Health, announced that the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, successfully defined the benefit of chemotherapy in early-stage breast cancer patients with Oncotype DX Breast Recurrence Score® results of 11 to 25. The long-awaited results of the TAILORx study, the largest ever breast cancer treatment trial, sponsored by the National Cancer Institute (NCI), and led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), provided definitive evidence that the Oncotype DX Breast Recurrence Score test identified 70 percent of early-stage breast cancer patients who receive no benefit from chemotherapy, and can be effectively treated with endocrine therapy alone. Additionally, the trial established that chemotherapy may provide life-saving benefit to 30 percent of patients.

The TAILORx results will be published June 3, 2018 in The New England Journal of Medicine in conjunction with a presentation during the Plenary Session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Click Here to read the entire press release from Genomic Health.

New FDA Approval for DARZALEX®

Janssen Biotech, Inc., is pleased to inform you that the US Food and Drug Administration has recently approved DARZALEX® (daratumumab) for use in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

DARZALEX® is the first and only CD38-targeted monoclonal antibody approved as monotherapy and in combination with other therapies for the treatment of multiple myeloma across various lines of therapy.

To learn more about the recent approval of DARZALEX®, view the press release or visit www.darzalexhcp.com.