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 

New FDA Approval for XGEVA®

On January 5, 2018, the U.S. Food and Drug Administration updated the U.S. Prescribing Information for XGEVA® (denosumab) to include patients with multiple myeloma*.  The new indication states:

XGEVA® is a RANK ligand (RANKL) inhibitor indicated for:

  • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors 

Please click here for current full Prescribing Information.

New FDA Approval for Pfizer's BOSULIF® (BOSUTINIB)

On December 19, 2017, the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

Pfizer Press Release:

https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_bosulif_bosutinib_for_the_treatment_of_patients_with_newly_diagnosed_ph_chronic_myelogenous_leukemia_cml

Prescribing information:

http://labeling.pfizer.com/ShowLabeling.aspx?id=884