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astrazeneca

FDA APPROVES NEW TREATMENT FOR PATIENTS WITH UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER FOLLOWING CRT

We are 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...

astrazeneca

FDA expands approval of AstraZeneca’s Imfinzi to reduce the risk of non-small cell lung cancer progressing

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III...

The U.S. Food and Drug Administration approved Janssen’s Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).

The U.S. Food and Drug Administration approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. “The FDA evaluates a variety of methods that measure a drug’s...

FDA approves new treatment for certain digestive tract cancers

The U.S. Food and Drug Administration  approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult...

FDA Warns About Anaphylaxis, Anaphylactic Shock With Use Of Rolapitant In Patients With Cancer.

A warning about anaphylaxis, anaphylactic shock, and other hypersensitivity reactions occurring with the use of rolapitant (Varubi, Tesaro Inc) in patients with cancer has been highlighted by the US Food and Drug Administration in a MedWatch bulletin. Rolapitant is a substance/ neurokinin receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer...

FDA Approves Addition Of Overall Survival Data To KYPROLIS® (carfilzomib) Label

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label demonstrated that KYPROLIS and dexamethasone (Kd) reduced the risk of death by...

teva oncology

Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on...

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations

On January 12, 2018, the Food and Drug Administration granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in 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. Approval was based on demonstration...

astrazeneca

FDA Approves First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast...

astrazeneca

LYNPARZA® (olaparib) Receives US FDA Approval for a New Indication

We are excited to announce on January 12, 2018, the FDA approved a new indication for the PARP inhibitor, LYNPARZA® (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy in the neoadjuvant, adjuvant...

astrazeneca

FDA approves AstraZeneca’s aparib for germline BRCA-mutated metastatic breast cancer

On January 12, 2018, the Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic...

Announcing a New Indication for a 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...

FDA Approved

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML)....

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab)

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease. Please click here for an announcement from Bristol-Myers Squibb.

The FDA Approved Perjeta® (pertuzumab)

The FDA recently approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. The Genentech press release including Important Safety Information is linked here. This approval is important because: It is based on results of the Phase...

FDA grants regular approval to nivolumab for adjuvant treatment of melanoma

On December 20, 2017, the Food and Drug Administration granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients...

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer

On December 20, 2017, the Food and Drug Administration granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval was based on data from APHINITY (NCT01358877), a multicenter, randomized, double-blind, placebo-controlled trial in...

FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma

Click here for corporate announcement.   On December 19, 2017, the Food and Drug Administration granted regular approval to cabozantinib (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved Cabometyx in 2016 for treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. Today’s approval...

pfizer

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML

On December 19, 2017, the Food and Drug Administration granted accelerated approval to bosutinib (BOSULIF, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). Approval was based on data from an open-label, randomized, multicenter trial (BFORE, NCT02130557) in 487 patients with Ph+ newly-diagnosed CP CML...

FDA approves Pfizer Biosimilar’s Ixifi (infliximab-qbtx)

FDA has approved Pfizer Biosimilar’s Ixifi (infliximab-qbtx) for multiple indications.  IXIFI or PF-06438179, infliximab-qbtx is a chimeric human-murine monoclonal antibody or mAb against tumor necrosis factor, as a biosimilar to Remicade or infliximab for all eligible indications of the reference product.This is the third FDA-approved biosimilar to U.S.-licensed Remicade.  For more information, see the approval...

Genentech Presented Data for Ten Medicines

This year at the American Society of Hematology (ASH) Annual Meeting, Genentech presented data for ten medicines in more than 75 abstracts [press release] including results for: VenclextaTM (venetoclax): Phase III data showing the chemotherapy-free, fixed-duration combination of Venclexta plus with Rituxan reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator)...

The Centers for Medicare and Medicaid Services (CMS) has granted BAVENCIO® (avelumab)

Effective for dates of service on or after January 1, 2018, the Centers for Medicare and Medicaid Services (CMS) has granted BAVENCIO® (avelumab) Injection the following permanent Healthcare Common Procedure Coding System (HCPCS) J-Code[1]: J9023 – injection, avelumab, 10mg Full Prescribing Information for BAVENCIO: https://www.bavencio.com/en_US/document/Prescribing-Information.pdf

The FDA has granted full approval for Avastin® (bevacizumab)

The FDA has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA’s accelerated approval program. The Genentech press release, which includes Important Safety Information is available at this link.

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