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Information for Sponsors: Submissions to the Office of Hematology and Oncology Products (OHOP)

This supersedes OHOP’s previously posted information for Sponsors dated September 12, 2011.

As differentiated below, OHOP management of new meeting requests and INDs occurs within the following clinical review divisions:  Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), and Division of Hematology Products (DHP): 

DOP 1DOP2DHP
Geoffrey Kim, M.D.
Division Director
Patricia Keegan, MD
Division Director
Ann Farrell, MD
Division Director
Breast, Gynecologic, Genitourinary, Supportive care (non-hematologic)
Gastrointestinal, Lung/Head & Neck, Neuro-oncology/Rare cancers/Pediatric Solid Tumor, Melanoma/Sarcoma
Benign hematology, Hematologic malignancies, Hematology support, Pediatric Hematology

Outlined below are OHOP’s general principles whether a new IND should be submitted or whether a new protocol can be submitted to an existing IND, as well as where to send meeting requests. If you have remaining questions regarding where/how to submit, a new IND, protocol, or meeting request, please contact the respective Division: 

DOP1DOP2DHP
Alice Kacuba, CPMS
(301) 796-1381
alice.kacuba@fda.hhs.gov

Christy Cottrell, CPMS
(301) 796-4256
christy.cottrell@fda.hhs.gov
Monica Hughes, CPMS
(301) 796-9225
monica.hughes@fda.hhs.gov

Melanie Pierce, CPMS 
(301)796-1273
Amy Baird, CPMS
(301) 796-4969
Theresa Carioti, CPMS
(301) 796-2848

Submission of Pre-IND Meeting Requests or New INDs Where a Specific Indication for Drug Development (or Specific Disease for Drug Investigation) HAS NOT yet been Identified:

If a Pre-IND meeting request or IND is submitted for Phase 1 study in “solid tumors only” whereby specific indications for drug development have not yet been identified (e.g., study is to investigate initial drug activity and safety in various solid tumors), the IND will be assigned to either DOP1 or DOP2 based upon an Office alternating allocation process. 

If a Pre-IND meeting request or IND is submitted for Phase 1 study in hematological indications, the IND will be assigned to DHP. 

If a Pre-IND meeting request or IND is submitted for Phase 1 study in “solid tumors and hematological indications”, whereby specific indications for drug development have not yet been identified (e.g., study is to investigate initial drug activity and safety in various solid tumors and hematological indications), the IND will be assigned to either DOP1, DOP2, or DHP based upon an Office alternating allocation process.

In the cover letter subject line of the submission, prominently identify the submission and proposed indication(s) as:

“Pre-IND MEETING REQUEST: SPECIFIC INDICATION NOT IDENTIFIED. SEVERAL TUMOR TYPES: [INSERT INDICATION(S)]” or “NEW IND: SPECIFIC INDICATION NOT IDENTIFIED. SEVERAL TUMOR TYPES: [INSERT INDICATIONS]”.

Submission of Pre-IND Meeting Requests or new INDs Where a Specific Indication for Drug Development HAS been Identified:

If a Pre-IND meeting request or IND is submitted for Phase 1 study for a specifically identified solid tumor or hematologic indication, the Division responsible for reviewing the indication will be assigned. 

In the cover letter subject line of the submission, prominently identify the submission and proposed indication as:

“Pre-IND MEETING REQUEST PROPOSED INDICATION [INSERT INDICATION]” or “NEW IND PROPOSED INDICATION [INSERT INDICATION]”.

Submission of New IND Containing Multiple Protocols:

If a IND is submitted that contains multiple protocols, separate INDs may be needed according to the general OHOP triage process as outlined below. 

Submission of New Protocols for Related or Similar Indications/Diseases:

In general, new protocols for a specific drug in related or similar diseases/indications may be submitted to an existing IND as indicated below. Please consult FDA’s Guidance for Industry: Codevelopment of Two or More New Investigational Drugs for Use in Combination regarding submission of protocols and INDs for codeveloped drugs.

DOP1:                                                                                      

  • Breast: All protocols for breast cancer indications can go under the same IND.
  • Gynecologic: All protocols for gynecologic cancer indications can go under the same IND (e.g., endometrial, ovarian, cervical).
  • Genitourinary: All protocols for genitourinary cancer indications can go under the same IND (e.g., renal cell, prostate, bladder).
DOP2:
  • Gastrointestinal: All protocols for gastrointestinal cancer indications can go under the same IND (e.g., pancreatic, hepatic, esophageal, biliary).
  • Thoracic, Head and Neck: All protocols for thoracic, head and neck cancer indications can go under the same IND (e.g., lung, mesothelioma, salivary gland).
  • Neuro-oncologic: All protocols for neurologic cancer indications can go under the same IND.
  • Melanoma: All protocols for adult melanoma indications can go under the same IND.
  • Sarcoma: All protocols for adult sarcoma indications can go under the same IND.
  • Rare solid tumors: All protocols for a specific rare tumor indication can go under the same IND (e.g., thyroid cancer).
  • Pediatric solid tumors: All protocols for pediatric solid tumor indications, including CNS tumors can go under the same IND.
DHP:
  • Hematologic malignancies including supportive care for transplant (blood, bone marrow, etc.) including GvHD. All protocols for hematologic malignancy indications can go under the same IND.
  • Benign hematology: All protocols for benign hematology indications can go under the same IND.
  • Pediatric Hematology including benign and malignant diseases can go under the same IND.

Submission of new protocols/INDs for unrelated indications/diseases WITHIN a review Division:

  • In general, a new Phase 1 protocol:

(1)    to determine initial activity and safety of the drug for an unrelated indication/disease (e.g., not meeting definitions of related or similar diseases/indications as noted above); or,

(2)    with no specific indication may be submitted to an existing IND, if the same division is responsible for reviewing the indication/disease. However, a new IND would generally be needed if there is further development (i.e., Phase 2, 3, or 4 protocol) of the drug in the unrelated indication/disease, even if the same division is responsible for reviewing the unrelated indication/disease. 

Submission of new protocols/INDs for unrelated indications/diseases THAT CROSS a review Division:

  • A new Phase 1, 2 or 3 protocol for an unrelated indication/disease than what is currently being studied under an IND should be submitted as a new IND if a different division is responsible for reviewing the indication/disease.

Expansion Cohorts:

  • Sponsors intending to use expansion cohorts should discuss their plans with the division prior to implementation as a new IND may be needed if the expansion cohort will be in an unrelated indication/disease and will be used to support a marketing application.  

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