Breakthrough Therapy Designation definition

Breakthrough Therapy Designation means “breakthrough therapy” designation granted by the FDA.
Sample 1Sample 2Sample 3
Breakthrough Therapy Designation means a drug designated by the FDA as a Breakthrough Therapy pursuant to Section 902 of the Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, 126 Stat. 993 (2012), as it may be amended from time to time, and the regulations promulgated thereunder.
Sample 1Sample 2Sample 3
Breakthrough Therapy Designation means, with respect to a Licensed Product, the approval of an application filed with the FDA granting such Licensed Product a “Breakthrough Therapy” designation in accordance with the rules and regulations promulgated under the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1Sample 2

Examples of Breakthrough Therapy Designation in a sentence

  • In March 2020, the Janssen Pharmaceutical Companies of Johnson & Johnson announced stated that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 for the treatment of patients with metastatic NSCLC with EGFR Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

  • In February 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to avasopasem for the reduction of SOM induced by radiotherapy with or without systemic therapy.

  • IMMU-132 has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease.

  • Deny Breakthrough Therapy Designation Reviewer Signature: {See appended electronic signature page} Team Leader Signature: {See appended electronic signature page} Division Director Signature: {See appended electronic signature page} Section II: If the BTDR cannot be denied without MPC review in accordance with numbers 1-3 above, or if the Division is recommending that the BTDR be granted, provide the following additional information needed by the MPC to evaluate the BTDR.

  • In February 2015, the FDA granted Rintega Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.

  • Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population.

  • Breakthrough Therapy Designation indicates that preliminary clinical evidence demonstrates the drug may have substantial improvement on one or more clinically significant endpoints over available therapy.

  • It received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with TNBC who have failed prior therapies for metastatic disease.

  • In February 2015, the U.S. Food and Drug Administration, or FDA, granted Rintega Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.

  • Actemra/RoActemra was granted Breakthrough Therapy Designation for SSc by the FDA in June 2015.


More Definitions of Breakthrough Therapy Designation

Breakthrough Therapy Designation means the FDA designation, described in section 506(a) of the FD&C Act. Such designation may be assigned to a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Sample 1Sample 2
Breakthrough Therapy Designation means, with respect to a Licensed Product, the approval of an application filed with the FDA granting such Licensed Product a “Breakthrough Therapy” designation in accordance with the rules and regulations promulgated under the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time.
Sample 1

Related to Breakthrough Therapy Designation

  • Step therapy protocol means a protocol or program that establishes the specific

  • Step therapy means a program for Insureds who take Prescription Drugs for an ongoing medical condition, such as arthritis, asthma or high blood pressure, which ensures the Insured receives the most appropriate and cost-effective drug therapy for their condition. The Step Therapy program requires that before benefits are payable for a high cost Covered Drug that may have initially been prescribed, the Insured try a lower cost first-step Covered Drug. If the prescribing Physician has documented with SHL why the Insured’s condition cannot be stabilized with the first-step Covered Drug, SHL will review a request for Prior Authorization to move the Insured to a second-step drug, and so on, until it is determined by SHL that the prescribed Covered Drug is Medically Necessary and eligible for benefit payment.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Physical therapy licensing board or "licensing board" means the agency of a state that is responsible for the licensing and regulation of physical therapists and physical therapist assistants.

  • Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Radiation therapy simulation system means a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Conversion therapy means any practice or treatment as defined in § 54.1-2409.5 A of the Code of Virginia.

  • Mental health therapist means the same as that term is defined in Section 58-60-102.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • Opium poppy means the plant of the species Papaver somniferum L., except its seeds.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Cardiopulmonary resuscitation or "CPR" means artificial ventilation or external chest compression applied to a person who is unresponsive and not breathing.

  • Type designation means a combination of letters and numerals assigned by the Government to a major end item, assembly or subassembly, as appropriate, to provide a convenient means of differentiating between items having the same basic name and to indicate modifications and changes thereto.

  • Behavioral therapy means interactive therapies derived from evidence-based research, including applied behavior analysis, which includes discrete trial training, pivotal response training, intensive intervention programs, and early intensive behavioral intervention.

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Radiation therapist means a person, other than a Licensed Practitioner or Nuclear Medicine Technologist, who applies radiation to humans for therapeutic purposes under the supervision of a Licensed Practitioner;

  • Non-Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Statewide popular election means a general election in which votes are cast for

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • ionising radiation means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less or a frequency of 3 x 1015 hertz or more capable of producing ions directly or indirectly;

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.