Table 3.
Summary of Genentech’s RTOR Experiencea
| Molecule | Type | Special Designations | Indication | Approval Timelineb (Months) | CDx | Project ORBIS |
|---|---|---|---|---|---|---|
| Kadcyla (ado-Trastuzumab emtansine) | sBLA | BTD, PR | HER2 + EBC | 3 |
Ventana PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay INFORM HER2 Dual ISH DNA Probe Cocktail assay |
No |
| Venclexta (venetoclax) | sNDA | BTD, ODD, PR | 1L CLL | 2 | N/A | No |
| Gavreto (pralsetinib) | NDA | AA, BTD, ODD, PR | RET mutation, fusion + LA MTC | 5 | N/A | No |
| Venclexta (venetoclax) | sNDA | AA, BTD, ODD, PR | 1L Unfit AML | 5 | N/A | Yes |
| Tecentriq (atezolizumab) | sBLA | BTD, ODD, PR | 1L HCC | 4.5 | N/A | Yes |
| Tecentriq (atezolizumab) | sBLA | N/A | Adj NSCLC | Ongoing | N/A | Yes |
aUp to July 2021
bAfter submission of final RTOR component
AA Accelerated approval, BTD breakthrough therapy designation, ODD orphan drug designation, PR priority review