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.

News from Genomic Health

Genomic Health Expands Offering to Prostate Cancer Patients with Launch of Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test to Predict Treatment Response in Metastatic Disease

New Liquid Biopsy Test Helps Physicians Select Most Effective Treatment, Prolonging Lives of Men with Metastatic Castration-resistant Prostate Cancer

On Feb. 26, 2018, Genomic Health, Inc. (NASDAQ: GHDX) announced the U.S. commercial launch of the Oncotype DX® AR-V7 Nucleus Detect™ test. The first and only liquid biopsy test of its kind, the Oncotype DX AR-V7 Nucleus Detect test was developed by Epic Sciences to help prolong the lives of men with metastatic castration-resistant prostate cancer (mCRPC) by accurately detecting a splice variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells (CTCs). Knowledge of a patient's AR-V7 status enables physicians to confidently decide whether men treated with an androgen receptor-signaling inhibitor (ARSI) therapy, such as enzalutamide and abiraterone, need to start another type of ARSI or switch to chemotherapy.

New formulation of IMBRUVICA®

Pharmacyclics LLC and Janssen Biotech, Inc., are pleased to share that they received US FDA approval for a new formulation of IMBRUVICA® as one pill, once a day. The same active ingredient is approved in one pill at multiple dosage strengths. No matter what dose a patient requires, they take just one pill a day. 

In addition, they recently received FDA approval for a new dosage strength of 70 mg for patients with moderate hepatic impairment or in patients with B-cell malignancies who are concomitantly taking specific posaconazole dosing regimens. Please refer to full IMBRUVICA® Prescribing Information for Dosing and Administration details.

Prescribing Information

NDC Flashcard

New FDA Approval for ERLEADA™

On February 14, 2018, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor, for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved treatment for these patients. This approval follows an FDA Priority Review designation based upon data from the Phase 3 SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC.

Click Here to read the Press Release from Janssen 

Click Here to read the FDA News Release

New FDA Approval for PERJETA

Genentech is excited to share the news of the FDA approval of PERJETA in combination with trastuzumab and chemotherapy as:

·  Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer 

·  Adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence

The FDA approval letter for PERJETA can be found at

 https://www.genentech-access.com/PERJETA

New FDA Indication for Gilotrif®

On January 16, 2018, Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I. The FDA granted Priority Review status to Gilotrif in evaluating this application. 

Click Here for Prescribing Information

For More Information: https://www.boehringer-ingelheim.us