Table 2.
Promising Late-Phase Drugs for Melanoma, Breast, and Lung Cancers
| Drug trade name (generic) | Manufacturer | Expected indication/therapeutic class/route | Development stage/comments (expected approval) |
|---|---|---|---|
| Melanoma | |||
| Talimogene laherparepvec (T-VEC) | Amgen | For metastatic melanoma that is not resectable; oncolytic immunotherapy; intralesional injection | NDA submitted PDUFA: 7/28/15 Submitted to EMA: 9/2014 |
| Cobimetinib (GDC-0973) | Genentech/Exelixis | For advanced melanoma with BRAF V600 mutation; a MEK inhibitor for use in combination with vemurafenib (Zelboraf), a BRAF inhibitor; oral | NDA: priority review PDUFA: 8/11/15 |
| Binimetinib | Array BioPharma | For metastatic melanoma with NRAS mutation; MEK inhibitor; oral | Phase 3 trials Est. NDA: mid-2016 |
| Selumetinib | Array BioPharma | For metastatic uveal melanoma; ATP inhibitor; oral | Phase 3 trials |
| Breast cancer | |||
| Entinostat | Syndax Pharmaceuticals | In combination with exemestane (Afinitor) for ER-positive metastatic breast cancer; HDAC inhibitor | Phase 3 trials BT: 9/12/13 |
| Veliparib (ABT-888) | AbbVie | PARP inhibitor for advanced BRCA1 or BRCA2 breast cancer, in combination with chemotherapy; oral | Phase 3 trials |
| Neratinib | Puma Biotechnology | For early-/late-stage HER2-positive breast cancer; TKI; oral | Phase 3 trials |
| Lung cancer | |||
| Necitumumab (IMC-11F8) | Eli Lilly | For advanced squamous NSCLC (in combination with gemcitabine plus cisplatin); recombinant human anti-EGFR immunoglobulin G1 monoclonal antibody | Est. approval 12/2015 FDA panel to discuss NDA: 7/9/15 |
| Iressa (gefitinib) | AstraZeneca | For first-line monotherapy of NSCLC with EGFR mutation; TKI; oral | NDA: 12/2/14 Est. approval 9/2015 |
| Rociletinib (CO-1686) | Clovis Oncology | For NSCLC with the EGFR T790M mutation after progression with anti-EGFR therapy; EGFR inhibitor TKI; oral | BT: 5/19/14 Est. NDA: mid-2015 |
| Atezolizumab (MPDL3280A) | Genentech | For patients with PD-1–positive NSCLC; PD-1–blocking immunotherapy | BT: 2/1/15 Phase 3 trials BT for metastatic bladder cancer: 2014 |
| Tafinlar (dabrafenib) | GlaxoSmithKline | For metastatic NSCLC with BRAF V600E mutation; a kinase inhibitor; oral | BT for NSCLC: 1/13/14 Phase 2 trials FDA approved for metastatic melanoma |
| Alectinib | Roche | For ALK-positive NSCLC that progressed with crizotinib; second-generation ALK inhibitor; oral | BT: 6/2013 Phase 2 trials Approved in Japan: 7/7/14 |
| Brigatinib (AP26113) | ARIAD Pharmaceuticals | For ALK-positive metastatic NSCLC resistant to crizotinib; a dual ALK/EGFR inhibitor; oral | BT: 10/2/14 NDA: mid-2016 |
| AZD-9291 | AstraZeneca | For patients with advanced NSCLC with EGFR mutation resistant to EGFR TKI therapy (ie, Iressa); EGFR inhibitor | Phase 2 trials: promising results Est. approval 2/2016 |
| Patritumab | Daiichi Sankyo | Human anti-HER3 antibody for the treatment of NSCLC; oral | Phase 2 trials |
ATP indicates adenosine triphosphate; BT, breakthrough therapy; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; ER, estrogen receptor; Est., estimated; FDA, US Food and Drug Administration; HDAC, histone deacetylase; NDA, New Drug Application; NSCLC, non–small-cell lung cancer; PARP, poly (ADP-ribose) polymerase; PD-1, programmed cell death receptor-1; PDUFA, Prescription Drug User Fee Act; TKI, tyrosine kinase inhibitor.