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FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL

On June 13, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Approval was based on data from 53 patients with relapsed or...

New indication for VENCLEXTA(R) (venetoclax tablets)

On June 8, 2018, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Genentech BioOncology® Access Solutions is your resource for access and...

FDA approves bevacizumab for ovarian cancer and pembrolizumab for large B-cell lymphoma cancer

Bevacizumab for Ovarian Cancer On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin®, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. Approval was based on GOG-0218 (NCT00262847),...

FDA Approves New Treatment for Women with Advanced Ovarian Cancer After Initial Surgery

Today, the FDA granted approval to Avastin in combination with chemotherapy, followed by Avastin alone, for the treatment of women with advanced (stage III or IV) ovarian cancer after initial surgery. The Genentech press release including Important Safety Information is linked here. This approval marks an important milestone in ovarian cancer, as this is the...

Eli Lilly and Company

FDA Expands Lilly’s ALIMTA® (pemetrexed) Label to Include Combination with KEYTRUDA® (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression

New approval based on KEYNOTE-021, Cohort G1, results INDIANAPOLIS, June 5, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA®(pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC),...

FDA approves Fulphila (pegfilgrastim-jmdb) to help reduce the risk of infection during cancer treatment

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are...

FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease

On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Approval was based on two international, identically designed, randomized, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2. Patients (n=430) with chronic liver disease and thrombocytopenia received either avatrombopag (n=274) or...

taiho oncology

Taiho Oncology Announces Positive Topline Results from Pivotal Phase 3 Trial of LONSURF® (trifluridine/tipiracil) in Metastatic Gastric Cancer

PRINCETON, N.J., May 9, 2018 – Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), and Servier, announced today that the pivotal Phase 3 (TAGS) trial evaluating LONSURF ® (trifluridine and tipiracil) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer, met its primary...

Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

RETACRIT, the First U.S. Biosimilar Erythropoiesis-Stimulating Agent (ESA), Now Approved Across All Indications NEW YORK, N.Y., May 15 – Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now...

Kymriah® (tisagenlecleucel), First-In-Class CAR-T Therapy From Novartis, Receives Second FDA Approval To Treat Appropriate R/R Patients With Large B-cell Lymphoma

(Novartis) May 1, 2018 – Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL),...

CMS Proposes Changes to Empower Patients and Reduce Administrative Burden

Changes in IPPS and LTCH PPS would advance price transparency and interoperability On April 24, CMS proposed changes to empower patients through better access to hospital price information, improve patients’ access to their electronic health records, and make it easier for providers to spend time with their patients. The proposed rule proposes updates to Medicare...

RITUXAN HYCELA: THE SAME ANTIBODY AS RITUXAN® (rituximab), DELIVERED SUBCUTANEOUSLY WITH HYALURONIDASE HUMAN IN 5-7 MINUTES

All patients must first receive at least one full dose of RITUXAN (rituximab) without experiencing severe adverse reactions before starting treatment with RITUXAN HYCELA due to the higher risk of hypersensitivity and other acute reactions during the first infusion Beginning therapy with RITUXAN allows management of hypersensitivity and other administration reactions by slowing or stopping...

astrazeneca

US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer

1st-line use of Tagrisso offers potential new standard of care Tagrisso delivered unprecedented median progression-free survival of 18.9 months versus 10.2 months compared with current standard of care   AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)...

FDA approves fostamatinib tablets for ITP

On April 17, 2018, the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Approval was based on two identical, double-blind, placebo-controlled trials, FIT-1 (NCT02076399) and FIT-2 (NCT02076412)...

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

 The Opdivo + low-dose Yervoy combination is the first and only treatment to show significantly superior overall survival versus sunitinib in intermediate- and poor-risk advanced renal cell carcinoma, including a survival benefit regardless of PD-L1 expression 1,2 Treatment with Opdivo + Yervoy delivered higher objective response rates, including more complete responses, than sunitinib 1,2 In the CheckMate -214 trial, which used dosing optimized for advanced renal...

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC...

FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures

On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell...

clovis oncology

FDA approves Clovis Oncology’s rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Approval was based on ARIEL3 (NCT01968213), a randomized, double-blind,...

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

On March 29, 2018, the Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approval was based on the open...

Nilotinib Approved to Treat Pediatric Patients with Leukemia

The FDA approved an expanded indication for nilotinib (Tasigna) as a first- and second-line treatment for pediatric patients 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP), according to a press release. Nilotinib is currently indicated to treat both adults and pediatric patients with newly-diagnosed Ph+ CML-CP. It is...

bayer health

NCCN Recommends Regorafenib Dose Escalation in Metastatic CRC

The NCCN guidelines were updated. CRC now includes the new dose escalation for Stivarga as a result of the ReDos study.  Read more at OncLive.com here http://www.onclive.com/web-exclusives/nccn-recommends-regorafenib-dose-escalation-in-metastatic-crc.

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. “Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,”...

FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications

On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will provide health-care professionals the flexibility to customize patient care with the option of using the...

Eli Lilly and Company

FDA Approval of New Indication for Verzenio™

February 26, 2018 – The US Food and Drug Administration (FDA) approved a new indication for Verzenio™ (abemaciclib 50, 100, 150, 200 mg tablets). See below for the Indication and Important Safety Information and click to access the full Prescribing Information for Verzenio.    Dosing Regimen Tablet Strength Quantity NDC* Days of Therapy per Pack Verzenio 7-Day Dose...

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