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.

New C-code For RITUXAN HYCELA™

The following is important information regarding a unique C-code that was recently assigned to RITUXAN HYCELA™ (rituximab/hyaluronidase human) by the Centers for Medicare & Medicaid Services (CMS). The C-code for RITUXAN HYCELA is C9467 (Injection, rituximab and hyaluronidase, 10 mg). 

The unique C-code went into effect on April 1, 2018. Payers may require its use until a permanent J-code is assigned. The permanent J-code is expected to be available for use starting on January 1, 2019. 

The C-code is used primarily in the Medicare hospital outpatient setting. Please check with your MAC to verify codes and any special billing requirements.

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

New Medicare Beneficiary Identifier (MBI)

The attached PDF provides important information about The Centers for Medicare & Medicaid (CMS) transition from the use of a Social Security number (SSN) to a Medicare Beneficiary Identifier (MBI) number, and how Genentech Access Solutions is addressing this conversion.

If you have any questions, please call Genentech Access Solutions at (866) 4ACCESS/ (866) 422-2377.

Click Below to access the PDF:

MBI Document

NEJM Article on KEYTRUDA® (pembrolizumab)

Merck is pleased to share an April 2018 New England Journal of Medicine publication that discusses KEYTRUDA® (pembrolizumab) plus chemotherapy in metastatic non-small-cell lung cancer.

Please click the link below to access the journal article. 

CLICK HERE TO ACCESS THE PUBLICATION

New FDA Approval for Opdivo® with Yervoy

On April 16, 2018, Bristol-Myers Squibb Company announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).1,2 In the Phase 3 CheckMate -214 clinical trial, the Opdivo + Yervoy combination demonstrated a significant and unprecedented increase in overall survival (OS) in this patient population compared to a current standard of care, sunitinib. An OS benefit was observed regardless of PD-L1 expression level.1,2,3 Opdivo + Yervoy also delivered durable responses, with a higher objective response rate (ORR) compared to sunitinib.1,2 Patients in the CheckMate -214 trial received four cycles of the Opdivo + low-dose Yervoy combination, followed by Opdivo maintenance therapy.1,2 In the combination arm of the trial, 79% of patients received all four doses of Opdivo + Yervoy and went on to the Opdivo monotherapy phase.4 Flexible dosing options are available during the Opdivo maintenance phase (480 mg infused every four weeks or 240 mg infused every two weeks).

“Our goal is to provide cancer patients with medicines that have the potential to extend their lives. As the first treatment option to increase overall survival for subgroups of patients with advanced RCC compared to sunitinib, the Opdivo plus low-dose Yervoy combination helps deliver on that promise,” said Johanna Mercier, head, U.S. Commercial, Bristol-Myers Squibb. “This approval demonstrates our commitment to bringing Immuno-Oncology treatments that may improve outcomes to a broader range of RCC patients.”

Click Here to read the entire press release.

New FDA Approval for IMFINZI® (durvalumab)

AstraZeneca Pharmaceuticals is pleased to inform you that the US Food and Drug Administration (FDA) has approved IMFINZI® (durvalumab)for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). 

There have been limited options over the past 10 years in this treatment setting. As of September 2017, the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) recommend durvalumab (IMFINZI) for unresectable Stage III NSCLC in patients whose disease has not progressed following platinum-based CRT.* The prior recommendation following CRT was a period of active surveillance. Up to 89% of these patients will progress to metastatic disease.

IMFINZI is the first and only FDA-approved treatment option in this setting, and we are thrilled to deliver this potentially practice-changing milestone for HCPs, and a critical milestone for patients in need of treatment options. In the Phase III PACIFIC trial, IMFINZI demonstrated an improvement in median progression-free survival (PFS) of 11.2 months compared to placebo (16.8 months for IMFINZI arm vs 5.6 months for placebo arm; hazard ratio 0.52; 95% CI, 0.42-0.65; p<0.0001).

IMFINZI, a human monoclonal antibody directed against PD-L1, is the cornerstone of AstraZeneca’s extensive Immuno-Oncology program across multiple cancer types and stages of disease. In lung cancer, IMFINZI is also being studied for the adjuvant treatment of patients with NSCLC, as well as for the 1st-line treatment of metastatic (Stage IV) NSCLC as monotherapy and in combination with tremelimumab, an investigational anti-CTLA-4 antibody, and chemotherapy. 

 

To learn more, please visit https://www.imfinzi.com/hcp.html.

News from Bristol-Myers Squibb on Opdivo Dosing

On March 6, 2018, Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.1 This approval will provide health care professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial.1 Opdivo also was approved for a shorter 30-minute infusion across all approved indications.1 Dosing schedule updates for an additional approved indication for Opdivo may be submitted to the FDA in the future.