LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI) today appear that the U.S. Aliment and Biologic Administration (FDA) has accustomed NERLYNX™ (neratinib), aforetime accepted as PB272, a once-daily articulate tyrosine kinase inhibitor for the connected accessory analysis of developed patients with aboriginal date HER2-overexpressed/amplified breast cancer, afterward accessory trastuzumab-based therapy. Puma expects neratinib to become commercially accessible in September 2017 and to be marketed as NERLYNX.
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FDA approval was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled balloon of neratinib afterward accessory trastuzumab treatment. Women (n=2,840) with early-stage HER2-positive breast blight and aural two years of commutual accessory trastuzumab were randomized to acquire either neratinib (n=1420) or placebo (n=1420) for one year.
The after-effects of the ExteNET balloon accustomed that afterwards two years of follow-up, invasive advantageous adaptation (iDFS) was 94.2% in patients advised with neratinib compared with 91.9% in those accepting placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008).
The best accepted adverse reactions (>5%) were diarrhea, nausea, belly pain, fatigue, vomiting, rash, stomatitis, decreased appetite, beef spasms, dyspepsia, AST or ALT increase, attach disorder, dry skin, belly distention, weight loss, and urinary amplitude infection. The best accepted adverse acknowledgment arch to cessation was diarrhea, which was empiric in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in alarmist transaminases led to biologic cessation in 1.7% of neratinib-treated patients.
"The abhorrence of ceremony is anytime present in the minds of best women with breast cancer, from the moment they are diagnosed to connected afterwards they accomplishment accessory treatment," said Marisa C. Weiss, M.D., Chief Medical Officer and Founder of Breastcancer.org. “New and able avant-garde ameliorative options accommodate huge achievement to patients and their families, giving them a bigger adventitious of advantageous breast blight with a adventitious for a abounding life.”
“Despite advances in the analysis of aboriginal date HER2-positive breast cancer, there charcoal a charge for added ameliorative improvements in adjustment to attack to added abate the accident of ache recurrence,” said Puma Biotechnology CEO and President Alan H. Auerbach. “We are admiring to be able to accompany this new anesthetic to patients with breast cancer. We would like to accurate our acknowledgment to the patients, caregivers and physicians who contributed to the neratinib analytic development affairs and, added specifically, the ExteNET trial.”
The abounding prescribing advice for NERLYNX will be fabricated accessible at WWW.NERLYNX.COM. The recommended dosage of NERLYNX is 240 mg (six 40 mg tablets) accustomed orally already circadian with food, continuously for one year. Antidiarrheal prophylaxis should be accomplished with the aboriginal NERLYNX dosage and connected during the aboriginal 2 cycles (56 days) of analysis and as bare thereafter. A Business Authorisation Appliance for neratinib is beneath analysis by the European Medicines Agency (EMA).
About HER2-Positive Breast Cancer
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Approximately 20 to 25 percent of breast blight tumors over-express the HER2 protein. HER2-positive breast blight is generally added advancing than added types of breast cancer, accretion the accident of ache progression and death. Although analysis has apparent that trastuzumab can abate the accident of aboriginal date HER2-positive breast blight abiding afterwards surgery, up to 25% of patients advised with trastuzumab acquaintance recurrence.
Indication
NERLYNX™ is a tyrosine kinase inhibitor adumbrated for the connected accessory analysis of developed patients with aboriginal date HER2-overexpressed/amplified breast cancer, to chase accessory trastuzumab-based therapy.
Patient Support
Puma has developed the Puma Accommodating Lynx abutment affairs to accommodate patients and healthcare providers with abetment accompanying to questions on accessing neratinib and referrals to assets that can advice with agreement and banking assistance. Added advice on the Puma Accommodating Lynx affairs can be begin at www.NERLYNX.com or (1-855-816-5421).
Important Safety Information
There are accessible ancillary furnishings of NERLYNX. Patients charge acquaintance their doctor appropriate abroad if they acquaintance any of these symptoms. NERLYNX analysis may be chock-full or the dosage may be bargain if the accommodating adventures any of these ancillary effects.
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Diarrhea
Diarrhea is a accepted ancillary aftereffect of NERLYNX. The diarrhea may be severe, and you may get dehydrated. Your healthcare provider should appoint the anesthetic loperamide for you during your aboriginal 2 cycles (56 days) of NERLYNX and again as needed. To advice anticipate or abate diarrhea:
Contact your healthcare provider appropriate abroad if you acquire astringent diarrhea or if you acquire diarrhea forth with weakness, dizziness, or fever.
Liver Problems
Changes in alarmist activity tests are accepted with NERLYNX. The patient’s doctor will do tests afore starting treatment, account during the aboriginal 3 months, and again every 3 months as bare during analysis with NERLYNX. NERLYNX analysis may be chock-full or the dosage may be bargain if your alarmist tests appearance astringent problems. Affection of alarmist problems may accommodate tiredness, nausea, vomiting, affliction in the appropriate high stomach-area (abdomen), fever, rash, itching, yellowing of your bark or whites of your eyes.
Pregnancy
Patients should acquaint their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. NERLYNX can abuse your approaching baby. Birth ascendancy should be acclimated while a accommodating is accepting NERLYNX and for at atomic 1 ages afterwards the aftermost dose. If patients are apparent to NERLYNX during pregnancy, they charge acquaintance their healthcare provider appropriate away.
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Common ancillary furnishings in patients advised with NERLYNX
In analytic studies, the best accepted ancillary furnishings apparent in patients demography NERLYNX were diarrhea, nausea, belly pain, fatigue, vomiting, rash, stomatitis (dry or affronted mouth, or aperture sores), decreased appetite, beef spasms, dyspepsia, changes in alarmist claret tests results, attach problems, dry skin, belly distention, weight loss, and urinary amplitude infection.
Patients should acquaint their doctor appropriate abroad if they are experiencing any ancillary effects. Address ancillary furnishings to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch. Patients and caregivers may additionally address ancillary furnishings to Puma Biotechnology at 1-844-NERLYNX (1-844-637-5969).
Please see Abounding Prescribing Information, accessible at www.NERLYNX.com.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical aggregation with a focus on the development and commercialization of avant-garde articles to enhance blight care. The Aggregation in-licenses the all-around development and commercialization rights to three biologic candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a almighty irreversible tyrosine kinase inhibitor that blocks arresting transduction through the epidermal advance agency receptors, HER1, HER2 and HER4. Currently, the Aggregation is primarily focused on the development of the articulate adaptation of neratinib, and its best avant-garde biologic candidates are directed at the analysis of HER2-positive breast cancer. The Aggregation believes that neratinib has analytic appliance in the analysis of several added cancers as well, including non-small corpuscle lung blight and added bump types that over-express or acquire a alteration in HER2. Added advice about Puma Biotechnology can be begin at www.pumabiotechnology.com.
Forward-Looking Statements
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This columnist absolution contains advanced statements, including statements apropos the Company’s apprehension that neratinib will become commercially accessible in September 2017. All advanced statements included in this columnist absolution absorb risks and uncertainties that could account the Company's absolute after-effects to alter materially from the advancing after-effects and expectations bidding in these advanced statements. These statements are based on accepted expectations, forecasts and assumptions, and absolute outcomes and after-effects could alter materially from these statements due to a cardinal of factors, which include, but are not bound to, the actuality that the Aggregation has no artefact acquirement and no articles accustomed for marketing, the Company's assurance on PB272, which is still beneath development and may never acquire authoritative approval, the challenges associated with administering and enrolling analytic trials, the accident that the after-effects of analytic trials may not abutment the Company's biologic applicant claims, alike if approved, the accident that physicians and patients may not acquire or use the Company's products, the Company's assurance on third parties to conduct its analytic trials and to codify and accomplish its biologic candidates, risks pertaining to balance chic action, acquired and aspersion lawsuits, the Company's assurance on accountant bookish property, and the added accident factors appear in the alternate and accepted letters filed by the Aggregation with the Balance and Exchange Commission from time to time, including the Company's Annual Address on Form 10-K for the year concluded December 31, 2016. Readers are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date hereof. The Aggregation assumes no obligation to amend these advanced statements, except as appropriate by law.
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