DOTA-TATE | Jotup

Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)

Retrieved on:

Thursday, January 11, 2024

Glomus tumor, Paragraph, Somatostatin, DOTA-TATE, Food, LNTH, FDA, Abbreviated New Drug Application, Certification

LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Key Points:

LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Based on the most recent update to the FDA’s online paragraph IV database listings,1 Lantheus believes it is the first applicant to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act.
Should its ANDA be approved by the FDA, Lantheus believes it will be eligible for 180 days of generic marketing exclusivity in the U.S.
Lantheus licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2003 from POINT Biopharma Global, Inc. in December of 2022.
To read the press release announcing that licensing transaction, please click here .

Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis

Retrieved on:

Friday, January 5, 2024

The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world.

Key Points:

The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world.
The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.
“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, President, Operations, Novartis.
Novartis is committed to expanding the radioligand therapy platform to shape the future of RLT as a treatment class.

Excel Diagnostics and Nuclear Oncology Center Announces FDA Authorization of IND for 225Ac-PSMA I&T Targeted Alpha Therapy for Castration Resistant Prostate Cancer

Retrieved on:

Wednesday, August 4, 2021

Branches of biology, Health sciences, Chemistry, Radiopharmaceuticals, Orphan drugs, Chelating agents, Macrocycles, Glutamate carboxypeptidase II, Proteases, MCRPC, DOTA-TATE, Prostate cancer

Houston, TX, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration-Resistant Prostate Cancer (mCRPC).

Key Points:

Houston, TX, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration-Resistant Prostate Cancer (mCRPC).
Excel Diagnostics and Nuclear Oncology Center has been a pioneer in bringing new targeted Radioligand Therapies such as Lu-177 DOTATATE, and Lu-177 PSMA to serve our patients in the United States.
Highly encouraging results have been reported by using Targeted Alpha Therapy (TAT) Radiopharmaceuticals in conditions such as neuroendocrine, prostate, or hematological malignancies.
In April of 2020, Excel passed FDA inspection of one of its investigational drugs with no deficiencies or citations.

RadioMedix & Curium Announce Detectnetᵀᴹ (copper Cu 64 dotatate injection) Inclusion on NCCN Guidelines®

Retrieved on:

Wednesday, May 5, 2021

Branches of biology, Medical specialties, Organ systems, Radiopharmaceuticals, Orphan drugs, G protein-coupled receptors, Neuroendocrinology, Chelating agents, Somatostatin receptor 2, DOTA-TATE, Neuroendocrine tumor, Copper (64Cu) oxodotreotide

Louis, MO, May 05, 2021 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that Detectnet is now included in the National Comprehensive Cancer Network\xc2\xae (NCCN) Clinical Practice Guidelines in Oncology \xe2\x80\x93 Neuroendocrine and Adrenal Tumors, version 1.2021 for the evaluation of neuroendocrine tumors (NETs).

Key Points:

Louis, MO, May 05, 2021 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that Detectnet is now included in the National Comprehensive Cancer Network\xc2\xae (NCCN) Clinical Practice Guidelines in Oncology \xe2\x80\x93 Neuroendocrine and Adrenal Tumors, version 1.2021 for the evaluation of neuroendocrine tumors (NETs).
Effective April 1, 2021, all sites of care will use code A9592 to submit for reimbursement for all patients.
\xe2\x80\x9cThe Phase III results demonstrate the high sensitivity, specificity, and accuracy of Detectnet.
In published trials nausea immediately after injection was observed.\nNon-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

RadioMedix & Curium Announce Detectnetᵀᴹ (copper Cu 64 dotatate injection) Inclusion on NCCN Guidelines®

Retrieved on:

Wednesday, May 5, 2021

Louis, MO, May 05, 2021 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that Detectnet is now included in the National Comprehensive Cancer Network\xc2\xae (NCCN) Clinical Practice Guidelines in Oncology \xe2\x80\x93 Neuroendocrine and Adrenal Tumors, version 1.2021 for the evaluation of neuroendocrine tumors (NETs).

Key Points:

Louis, MO, May 05, 2021 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that Detectnet is now included in the National Comprehensive Cancer Network\xc2\xae (NCCN) Clinical Practice Guidelines in Oncology \xe2\x80\x93 Neuroendocrine and Adrenal Tumors, version 1.2021 for the evaluation of neuroendocrine tumors (NETs).
Effective April 1, 2021, all sites of care will use code A9592 to submit for reimbursement for all patients.
\xe2\x80\x9cThe Phase III results demonstrate the high sensitivity, specificity, and accuracy of Detectnet.
In published trials nausea immediately after injection was observed.\nNon-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

RadioMedix & Curium Announce Simplified Coding for DetectnetTM (copper Cu 64 dotatate injection)

Retrieved on:

Tuesday, March 23, 2021

Orphan drugs, Radiopharmaceuticals, Branches of biology, Drugs, Medicine, G protein-coupled receptors, Chelating agents, Macrocycles, DOTA-TATE, Somatostatin receptor 2, Copper (64Cu) oxodotreotide, Somatostatin

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

Key Points:

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.
The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors.
A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.
Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

RadioMedix & Curium Announce Permanent HCPCS Code for DetectnetTM (copper Cu 64 dotatate injection)

Retrieved on:

Tuesday, January 26, 2021

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

Key Points:

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.
The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors.
A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.
Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

POINT Biopharma Signs Exclusive License Agreement with CanProbe for the Commercialization of a Neuroendocrine Tumor Treatment

Retrieved on:

Tuesday, January 12, 2021

Orphan drugs, DOTA-TATE, Macrocycles, Radiopharmaceuticals, Chemistry, Chemical substances, Physical sciences

CanProbes NET clinical program has helped many patients in Ontario who previously had no other options for treatment, says Dr. Joe McCann, Chief Executive Officer of POINT Biopharma.

Key Points:

CanProbes NET clinical program has helped many patients in Ontario who previously had no other options for treatment, says Dr. Joe McCann, Chief Executive Officer of POINT Biopharma.
We are looking forward to working with POINT Biopharma on the commercialization of Lu-DOTATATE, says Dr. Luke Brzozowski, President of CanProbe.
We believe POINT is the ideal partner to make this treatment accessible to patients in Ontario and across the globe.
POINT Biopharma is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer.

RadioMedix & Curium Announce CMS Transitional Pass-Through Status for Detectnet™ (copper Cu 64 dotatate injection)

Retrieved on:

Wednesday, December 9, 2020

Branches of biology, Radiopharmaceuticals, Chemistry, Physical sciences, Chelating agents, Macrocycles, Neuroendocrinology, G protein-coupled receptors, DOTA-TATE, Copper (64Cu) oxodotreotide, Somatostatin receptor 2, Neuroendocrine tumor

The response to Detectnet in the neuroendocrine community has been tremendous, said Curium CEO, North America, Dan Brague.

Key Points:

The response to Detectnet in the neuroendocrine community has been tremendous, said Curium CEO, North America, Dan Brague.
The recent inclusion in a major Appropriate Use Criteria confirms the clinical utility of Detectnet in the neuroendocrine community, said Ebrahim Delpassand, MD, CEO of RadioMedix.
Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).

RadioMedix and Curium Announce FDA Approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.

Retrieved on:

Tuesday, September 8, 2020

Branches of biology, G protein-coupled receptors, Organ systems, Medicine, Neuroendocrinology, Somatostatin receptor 2, DOTA-TATE, Somatostatin, Peptide receptor radionuclide therapy, Advanced Accelerator Applications

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

Key Points:

Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.
The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors.
A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.
Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2).