Epizyme Launches EZH2Now Testing Program with Quest Diagnostics for Relapsed or Refractory Follicular Lymphoma Patients

EZH2Now Testing Program is first of its kind to offer national single gene testing for EZH2

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today launched the EZH2Now Testing Program, an Epizyme initiative in collaboration with Quest Diagnostics (NYSE: DGX), the leading provider of diagnostic information services, to provide EZH2 mutation testing for patients with relapsed or refractory (R/R) follicular lymphoma (FL).

“Epizyme is focused on providing access to information that will help physicians and their patients evolve the treatment of relapsed or refractory follicular lymphoma,” said Vicki Vakiener, Chief Commercial Officer at Epizyme. “While EZH2 is known to be a driver of FL regardless of mutation status, access to testing for EZH2 is desirable for some providers. Even though Next Generation Sequencing is commercially available, a number of physicians desire a single gene test. To meet the needs of these providers, Epizyme is collaborating with Quest Diagnostics to improve access to single gene testing for relapsed or refractory follicular lymphoma patients.”

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CoPay Accumulator Patient Resources

Educate your patients with resources like this CoPay Accumulator video along with our printable brochures that will provide valuable information to your patients as they manage the financial impact of copay accumulator programs.

NCODA’s Legislative & Policy Advisory Committee continues to push for increased awareness to help patience afford their medications with copay assistance. For more information on the LPAC Committee, click here.

 

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FOR IMMEDIATE RELEASE
June 29th 2021

 

STATEMENT FROM NCODA Legislative & Policy Advisory Committee
Contact: Kevin Scorsone | NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email: kevin.scorsone@ncoda.org
www.ncoda.org

LOUISIANA SIGNS LAW TO PROHIBIT WHITE BAGGING

June has been filled with announcements and progress in the world of oncology at state legislatures throughout the United States. 

The Governor of Louisiana recently signed legislation that would prohibit “white bagging”. The term “white bagging” relates to drugs that are delivered to an oncology practice from an insurance provider’s preferred pharmacy. This practice is another example of limiting patients timely access to their preferred medication and has increasingly caused concern to the safety and well-being of patients.

NCODA applauds the decision by the Louisiana state legislature and the Governor to prohibit “white bagging” throughout the state. This law will guarantee that health insurance companies cannot refuse to pay for drugs that have been prescribed by physicians to insured Louisiana patients. This is a momentous bill signing and marks the first of its kind in the U.S.
           
NCODA has featured discussions on “white and brown bagging” at our Fall Summit and Spring Forum and those conversations were focused on the pitfalls of the onerous practice of drugs being supplied by an outside entity to practices, including treatment delays, excessive waste, burdensome inventory management  and other factors that disrupt patient care. 

It is our hope that legislative victories such as this will start a chain reaction in other states that will continue to focus on improving patient outcomes, and put  patients’ needs and well-being at the forefront of care. 

NCODA will continue to update our membership with any additional details and progress made with this issue.  

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CONTACTS: Jacquie Ross, Investors (650) 358-1054 Mary Lynn Carver, Media (410) 443-1853

 

For Immediate Release

KITE ANNOUNCES YESCARTA® CAR T-CELL THERAPY IMPROVED EVENT-FREE SURVIVAL BY 60% OVER CHEMOTHERAPY PLUS STEM CELL TRANSPLANT IN SECONDLINE RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA

— Landmark ZUMA-7 Study was Initiated in 2017 as the First Randomized Clinical Trial to Test the Earlier Use of a CAR T-cell Therapy Against Standard of Care —

— Study Met the Primary and Key Secondary Endpoints of Event-Free Survival and Objective Response Rate, Demonstrating a Highly Statistically and Clinically Significant Improvement Compared to Standard of Care —

Santa Monica, Calif., – June 28, 2021 – Kite, a Gilead Company (Nasdaq: GILD), today announced top-line results from the primary analysis of ZUMA-7, a randomized Phase 3 global, multicenter study showing superiority of Yescarta® (axicabtagene ciloleucel) compared to standard of care (SOC) in second-line relapsed or refractory large B-cell lymphoma (LBCL). With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future. Read more HERE.

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WHIPPANY, N.J., June 23, 2021 – Bayer announced the availability of new packaging for the company’s treatment Stivarga® (regorafenib) to support dispensing. Stivarga is now available in four 21-count bottles, replacing the previous packaging of three 28-count bottles.

 

“The new packaging contains four 21-count bottles to help further accommodate dispensing of Stivarga,” said Ray Bailey, RPh, Director of Pharmacy of Florida Cancer Specialists and Research. “The streamlined packaging is a welcome change to help improve the dispensing experience for pharmacists and physicians.”

 

About Stivarga® (regorafenib)

In April 2017, Stivarga was approved for use in patients with hepatocellular carcinoma who have been previously treated with Nexavar® (sorafenib). In the United States, Stivarga is also indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

 

Important Safety Information for STIVARGA® (regorafenib)

 

Hepatotoxicity: Severe drug-induced liver injury with fatal outcome occurred in STIVARGA-treated patients across all clinical trials. In most cases, liver dysfunction occurred within the first 2 months of therapy and was characterized by a hepatocellular pattern of injury. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of patients in the placebo arm. In gastrointestinal stromal tumor (GIST)fatal hepatic failure occurred in 0.8% of patients in the STIVARGA arm. In hepatocellular carcinoma (HCC), there was no increase in the incidence of fatal hepatic failure as compared to placebo.

 

Liver Function Monitoring: Obtain liver function tests (ALT, AST, and bilirubin) before initiation of STIVARGA and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue STIVARGA, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.

 

Infections: STIVARGA caused an increased risk of infections. The overall incidence of infection (Grades 1-5) was higher (32% vs 17%) in 1142 STIVARGA-treated patients as compared to the control arm in randomized placebo-controlled trials. The incidence of grade 3 or greater infections in STIVARGA treated patients was 9%. The most common infections were urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) and pneumonia (2.6%). Fatal outcomes caused by infection occurred more often in patients treated with STIVARGA (1.0%) as compared to patients receiving placebo (0.3%); the most common fatal infections were respiratory (0.6% vs 0.2%). Withhold STIVARGA for Grade 3 or 4 infections, or worsening infection of any grade. Resume STIVARGA at the same dose following resolution of infection.

 

Hemorrhage: STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 18.2% in 1142 patients treated with STIVARGA vs 9.5% with placebo in randomized, placebo-controlled trials. The incidence of grade 3 or greater hemorrhage in patients treated with STIVARGA was 3.0%. The incidence of fatal hemorrhagic events was 0.7%, involving the central nervous system or the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue STIVARGA in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.

 

Gastrointestinal Perforation or Fistula: Gastrointestinal perforation occurred in 0.6% of 4518 patients treated with STIVARGA across all clinical trials of STIVARGA administered as a single agent; this included eight fatal events. Gastrointestinal fistula occurred in 0.8% of patients treated with STIVARGA and in 0.2% of patients in the placebo arm across randomized, placebo-controlled trials. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula.

 

Dermatological Toxicity: In randomized, placebo-controlled trials, adverse skin reactions occurred in 71.9% of patients with STIVARGA arm and 25.5% of patients in the placebo arm including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia syndrome (PPES) and severe rash, requiring dose modification. In the randomized, placebo-controlled trials, the overall incidence of HFSR was higher in 1142 STIVARGA-treated patients (53% vs 8%) than in the placebo-treated patients. Most cases of HFSR in STIVARGA-treated patients appeared during the first cycle of treatment. The incidences of Grade 3 HFSR (16% vs <1%), Grade 3 rash (3% vs <1%), serious adverse reactions of erythema multiforme (<0.1% vs 0%), and Stevens-Johnson syndrome (<0.1% vs 0%) were higher in STIVARGA-treated patients. Across all trials, a higher incidence of HFSR was observed in Asian patients treated with STIVARGA (all grades: 72%; Grade 3:18%). Toxic epidermal necrolysis occurred in 0.02% of 4518 STIVARGA-treated patients across all clinical trials of STIVARGA administered as a single agent. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.

 

Hypertension: Hypertensive crisis occurred in 0.2% in STIVARGA-treated patients and in none of the patients in placebo arm across all randomized, placebo-controlled trials. STIVARGA caused an increased incidence of hypertension (30% vs 8% in mCRC, 59% vs 27% in GIST, and 31% vs6% in HCC). The onset of hypertension occurred during the first cycle of treatment in most patients who developed hypertension (67% in randomized, placebo-controlled trials). Do not initiate STIVARGA until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold STIVARGA for severe or uncontrolled hypertension.

 

Cardiac Ischemia and Infarction: STIVARGA increased the incidence of myocardial ischemia and infarction (0.9% with STIVARGA vs 0.2% with placebo) in randomized placebo-controlled trials. Withhold STIVARGA in patients who develop new or acute cardiac ischemia or infarction and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia.

 

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Reversible posterior

leukoencephalopathy syndrome (RPLS), a syndrome of subcortial vasogenic edema diagnosed by characteristic finding on MRI occurred in one of 4800 STIVARGA-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, severe headache, visual disturbances, confusion, or altered mental function. Discontinue STIVARGA in patients who develop RPLS.

 

Wound Healing Complications: Impaired wound healing complications can occur in patients who receive drugs that inhibit the VEGF signaling pathway. Therefore, STIVARGA has the potential to adversely affect wound healing. Withhold STIVARGA for at least 2 weeks prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of STIVARGA after resolution of wound healing complications has not been established.

 

Embryo-Fetal Toxicity: STIVARGA can cause fetal harm when administered to a pregnant woman. There are no available data on STIVARGA use in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with STIVARGA and for 2 months after the final dose.

 

Nursing Mothers: Because of the potential for serious adverse reactions in breast fed infants from STIVARGA, do not breastfeed during treatment with STIVARGA and for 2 weeks after the final dose.

 

Most Frequently Observed Adverse Drug Reactions in mCRC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), pain (59% vs 48%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).

 

Most Frequently Observed Adverse Drug Reactions in GIST (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo treated patients in GIST, respectively, were: HFSR/PPE (67% vs 12%), pain (60% vs 55%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).

 

Most Frequently Observed Adverse Drug Reactions in HCC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in HCC, respectively, were: pain (55% vs 44%), HFSR/PPE (51% vs 7%), asthenia/fatigue (42% vs 33%), diarrhea (41% vs 15%), hypertension (31% vs 6%), infection (31%vs 18%), decreased appetite and food intake (31% vs 15%).

 

Please see full Prescribing Information, including Boxed Warning for Stivarga (regorafenib).

 

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

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© 2021 Bayer

BAYER, the Bayer Cross and Stivarga are registered trademarks of Bayer.

 

Media Contact:

Rose Talarico, Tel. +1 862.404.5302

E-Mail: rose.talarico@bayer.com

 

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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