SIDEBAR: 2013 New Drug/Indication Approvals* 


Get Permission

1. September 30, 2013: Pertuzumab (Perjeta) Accelerated approval in combination with trastuzumab and docetaxel for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. 

2. September 6, 2013: Paclitaxel protein-bound particles (albumin-bound) (Abraxane) in combination with gemcitabine for the first-line treatment of metastatic pancreatic adenocarcinoma.

3. July 12, 2013: Afatinib (Gilotrif tablets) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Therascreen EGFR RGQ PCR Kit (Qiagen) was approved concurrently for detection of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

4. June 13, 2013: Denosumab (Xgeva injection) for the treatment of giant cell tumor of bone.

June 5, 2013: Lenalidomide capsules (Revlimid) for the treatment of mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade).

5. May 29, 2013: Trametinib (Mekinist tablet) for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutation.

6. May 29, 2013: Dabrafenib (Tafinlar capsule) for the treatment unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

7. May 15, 2013: Radium Ra 223 dichloride (Xofigo injection) for the treatment of castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.  

8. May 14, 2013: Erlotinib (Tarceva) for the first-line treatment of metastatic non-small cell lung cancer patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.  This indication for erlotinib was approved concurrently with the Cobas EGFR Mutation Test, a companion diagnostic test for patient selection.

9. February 22, 2013: Ado-trastuzumab emtansine (Kadcyla for injection) for use as a single agent for the treatment of HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. 

10. February 8, 2013: Accelerated approval to pomalidomide (Pomalyst capsules) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on or within 60 days of completion of the last therapy. 

11. February 4, 2013: Doxorubicin hydrochloride liposome injection, a generic version of Doxil Injection (doxorubicin hydrochloride liposome) for the treatment of ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy and for AIDS-related Kaposi’s sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy.

12. January 23, 2013: Bevacizumab (Avastin) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of metastatic colorectal cancer that has progressed on a first-line bevacizumab-containing regimen.

13. January 23, 2013: Bevacizumab (Avastin) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of metastatic colorectal cancer that has progressed on a first-line bevacizumab-containing regimen. ■

*Approvals as of October 21, 2013.


Related Articles

A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine

Dubbed “Cancer Czar” by the media, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Office of Hematology and Oncology Products, said he has the “best job in oncology, with a unique vantage point in cancer drug development.” An oncologist for more than 30 years—including...


Advertisement

Advertisement



Advertisement