Outlined below are OOD’s general principles regarding submission of new meeting requests, new INDs and new protocols. If you have remaining questions regarding where/how to submit, a new IND, protocol, or meeting request, please contact the CPMS for the DRO-OD team supporting the clinical review division that you think is most appropriate for the meeting request, IND, or protocol. 

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 to study various solid tumors 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 generally be assigned to either DO1, DO2, or DO3 based upon an Office alternating allocation process. 

If a Pre-IND meeting request or IND is submitted to study various hematologic malignancy indications, the IND will be assigned to either DHM1 or DHM2. 

If a Pre-IND meeting request or IND is submitted to study various solid tumors and hematologic malignancy 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 hematologic malignancy indications), the IND will be assigned to either DO1, DO2, DO3, DHM1, or DHM2 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 to study a specifically identified solid tumor or hematologic malignancy 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 an IND is submitted that contains multiple protocols, separate INDs may be needed so that the development program can be reviewed by the team specializing in the specific indication(s). 

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.

DO1:                                                                                      

• 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).
• Oncology Supportive care: All protocols for oncology supportive care other than hematologic growth factor support can go under the same IND.

DO2:

• Thoracic, Head and Neck: All protocols for thoracic, head and neck cancer indications may be submitted under the same IND (e.g., lung, mesothelioma, salivary gland) depending on the extent of the development program.
• Neuro-oncologic: All protocols for neurologic cancer indications can go under the same IND.
• Rare solid tumors: All protocols for a specific rare tumor indication (e.g., thyroid cancer) or for a biomarker-defined, tumor agnostic indication can go under the same IND (e.g., NTRK fusion-positive tumors).
• Pediatric solid tumors: All protocols for specified pediatric solid tumor indications, including CNS tumors for early stage studies, can go under the same IND.

DO3:

• Gastrointestinal: All protocols for gastrointestinal cancer indications may be submitted under the same IND (e.g., pancreatic, hepatic, esophageal, biliary) depending on the extent of the development program.
• Cutaneous: All protocols for adult melanoma and Non-melanomatous skin cancer can go under the same IND.
• Sarcoma: All protocols for adult sarcoma indications can go under the same IND.

DHM1:

• All protocols for acute leukemia and myelodysplasia (includes myelodysplastic-myeloproliferative overlap syndromes), chronic myeloid leukemia and other myeloproliferative neoplasms with the term “leukemia”, blastic plasmacytoid dendritic cell neoplasm (BPDCN), conditioning regimens for DHM1 indications, graft versus host disease, tumor lysis syndrome, cytokine release syndrome, and CAR-T neurotoxicity can go under the same IND.
• Myelodysplastic syndromes

DHM2:

• All protocols for adult and pediatric lymphoma, chronic lymphocytic leukemia, multiple myeloma, or other plasma cell malignancies can go under the same IND.

All applications for nonmalignant indications will be handled by the remaining staff in the Division of Hematology Products and under the Office of Drug Evaluation 1.

Non-malignant hematology products: All INDs, NDAs, and BLAs for myeloproliferative disorders, lymphoproliferative disorders (including Castleman’s), white cell disorders including mobilization, mast cell and histiocytic disorders (including Langherans, Erdheim-Chester), red cell disorders including nutritional, destructive, sickle cell, thalassemia, platelet disorders, hemostasis and thrombosis, and bone marrow failure syndromes.

Office Director – Ellis Unger, MD

Division of Hematology Products

• Ann Farrell, MD, Division Director
• Albert Deisseroth, MD, PhD, Deputy Director

Applications for non-malignant hematology indications should be addressed to:

Ann Farrell, MD, Division Director, Office of Drug Evaluation I (ODE I), Division of Hematology Products (DHP).

Questions regarding application submissions for DHP should be directed to Charlene Wheeler, Acting Chief Project Management Staff (CPMS) at (301) 796-1141 or [email protected].

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 and Master Protocols:

• Sponsors intending to conduct clinical trials that utilize multiple expansion cohorts for early activity estimation or for estimation of activity or demonstration of clinical benefit in support of regulatory approval (as discussed in the draft FDA guidances for industry, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics (August 2018) and Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics (October 2018), respectively) should submit a meeting request to discuss their plans with the division prior to submission of the protocol or prior to amending an ongoing protocol in the event that a new IND is needed.