Lutathera & Pluvicto
Closed Special Notice Posted
- Solicitation number
- W81K0022Q0097
- Agency
-
Medical Command
Department of the Army, Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Jbsa Ft Sam Houston, Texas 78234, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Regional Health Contracting Office-Central, under the Department of the Army Medical Command, published a Special Notice regarding a sole source contract award for two FDA approved pharmaceutical products, Lutathera and Pluvicto. The Special Notice provides details on requirements and characteristics for the pharmaceuticals to be procured.
The Special Notice communicates the intent to award a firm-fixed-price sole source contract to Advance Accelerator Applications USA, Inc. under FAR 13.501(a)(1)(ii) for Lutathera and Pluvicto. Interested parties must submit any responses by May 30, 2022 at 10:00 AM CST for consideration. Lutathera must be Lu-177 Dotatate indicated for treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Pluvicto must be Lu-177 Vipivotide Tetraxetan indicated for treatment of prostate-specific membrane antigen positive metastatic castration resistant prostate cancer in adult patients. The contract award will be made on or after August 1, 2022 to a firm classified under NAICS code 325412 with a size standard of 1,250 employees or fewer.
Notice text
The Regional Health Contracting Office-Central, JBSA - Fort Sam Houston, Texas intends to award a Firm-Fixed-Price sole source contract to Advance Accelerator Applications USA, Inc. under the authority of Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source, for the requirement for two FDA approved products LUTATHERA (lutetium Lu 177 dotatate) and PLUVICTO (lutetium Lu 177 vipivotide tetraxetan). Lutathera is indicated for the imaging and treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors for patients. Pluvicto is for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration resistant prostate cancer.
The applicable NAICS code for this requirement is 325412, Pharmaceutical Preparation Manufacturing. The Small Business Size Standard is 1,250 employees. Award will be made on or after 1 Aug 2022.
The solicitation number is W81K0022Q0097, and is generated for the purposes of posting this notice. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. A determination by the Government not to compete the purchase order based upon responses to this notice is solely within the discretion of the Government. This notice is neither a request for quotes nor a solicitation of offers; however, interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. Questions will not be accepted after the due date. All responses must be received by 30 May 2022-10:00AM CST
Salient Characteristics:
Lutetium Lu-177 Dotatate (LUTATHERA)
Must be FDA approved.
Must be Lu-177 Dotatate
Must be indicated for treatment of somatostatin receptor-positive gastroenterpancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
Should be a 4 dose treatment regimen given every 8 weeks.
Lutetium Lu-177 Vipivotide Tetraxetan (PLUVICTO)
Must be FDA approved
Must be Lu-177 Vipivotide Tetraxetan
Must be indicated for treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Should be a treatment regimen of every 6 weeks for up to 6 doses.
Contracting Office Address:
Regional Healthcare Contracting Office- Central
Attn: MCAA-RC, 3551 Roger Brooke Drive
JBSA-Fort Sam Houston, TX 78234-6200
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Special Notice | |
| Lutathera & Pluvicto | Pre-Solicitation |
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