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   

American Joint Commission of Cancer (AJCC) Incorporates the Oncotype DX Breast Recurrence Score in Its Cancer Staging Manual; Recognizes Role of Oncotype DX in Classifying Patients

The AJCC has announced that the Oncotype DX Breast Recurrence Score® will be added to its latest criteria for staging breast cancer patients. This is the first and only molecular marker incorporated in the staging criteria, along with estrogen receptor (ER), progesterone receptor (PR) and HER2 status. This milestone decision marks the transition of cancer care and diagnosis to personalized medicine, recognizing the value of genomic testing to more precisely define prognosis and tailor treatment to the individual biology of each patient’s disease.

New FDA Approval for CINVANTI™

On Nov. 9, 2017, Heron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved CINVANTI™(aprepitant) injectable emulsion, for intravenous infusion. CINVANTI is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). With this approval, Heron now is the only company with approved injectable therapies that address the two primary mechanisms of CINV: SUSTOL®, a serotonin-3 (5-HT3) receptor antagonist, and CINVANTI, an NK1 receptor antagonist.

Click Here for full prescribing information: www.CINVANTI.com