A Look Back at FDA News in the Month of May

Durvalumab Approved by the FDA for Bladder Cancer

On the first of May, the PD-L1 inhibitor durvalumab (Imfinzi) was granted an accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. A complementary diagnostic, the VENTANA PD-L1 (SP263) Assay, was simultaneously approved for PD-L1 expression assessment.

http://www.targetedonc.com/news/durvalumab-approved-by-fda-for-bladder-cancer

Avelumab Was Approved For Patients With Bladder Cancer by the FDA

The FDA has granted an accelerated approval to the PD-L1 inhibitor avelumab (Bavencio) for the treatment of patients with locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

http://www.targetedonc.com/news/avelumab-approved-by-fda-for-bladder-cancer

FDA Approved Co-packaging of Ribociclib With Letrozole for Metastatic Breast Cancer

The FDA granted an approval to co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) on May 9 for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer. With the new Kisqali Femara Co-Pack, patients can obtain full cycles of both medicines in 1 package with 1 prescription and 1 copay, and the cost will be the same as that for Kisqali alone, according to Novartis, which manufactures both medications.

http://www.targetedonc.com/news/fda-grants-approval-to-copackaging-of-ribociclib-with-letrozole-for-metastatic-breast-cancer

Frontline Pembrolizumab Combination Was Approved by FDA for NSCLC

Pembrolizumab (Keytruda) was granted an accelerated approval by the FDA on May 10 for use in combination with pemetrexed plus carboplatin as a frontline treatment for patients with metastatic or advanced nonsquamous non—small cell lung cancer (NSCLC), regardless of PD-L1 expression.

http://www.targetedonc.com/news/frontline-pembrolizumab-combo-approved-by-fda-for-nsclc

Entrectinib Granted a Breakthrough Designation by FDA forNTRK+ Solid Tumors

Entrectinib was granted a breakthrough therapy designation by the FDA on May 16 for use as a treatment for adult and pediatric patients withNTRK-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or who have no available acceptable standard therapies, according to Ignyta, the manufacturer of the multikinase inhibitor.

http://www.targetedonc.com/news/entrectinib-granted-breakthrough-designation-by-fda-for-ntrk-solid-tumors

Copanlisib Granted a Priority Review by FDA for Follicular Lymphoma

Copanlisib was granted a priority review designation by the FDA on May 17 as a treatment for patients with relapsed/refractory follicular lymphoma who have received at least 2 prior therapies, according to Bayer, the manufacturer of the PI3K dual-isoform inhibitor.

http://www.targetedonc.com/news/copanlisib-granted-priority-review-designation-by-fda-for-follicular-lymphoma

Pembrolizumab Approved in Urothelial Carcinoma

Pembrolizumab (Keytruda) was approved by the FDA on May 17 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

http://www.targetedonc.com/news/pembrolizumab-approved-by-the-fda-for-urothelial-carcinoma

Pembrolizumab Approved by the FDA for Microsatellite Instability-High and Mismatch Repair Deficient Cancers

Pembrolizumab (Keytruda) was granted an accelerated approval by the FDA on May 23 for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options, as well as for patients with MSI-H or dMMR colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

http://www.targetedonc.com/news/pembrolizumab-approved-by-the-fda-for-microsatellite-instabilityhigh-and-mismatch-repair-deficient-cancers

Neratinib Received Support for Approval in HER2-Positive Breast Cancer from FDA Panel

Neratinib (Nerlynx) was recommended for approval by the FDA’s Oncologic Drugs Advisory Committee (ODAC) in a 12-4 vote on May 24 for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin).

http://www.targetedonc.com/news/neratinib-receives-fda-panel-support-for-approval-in-her2positive-breast-cancer

Pembrolizumab Granted Priority Review by the FDA for Advanced Gastric Cancer

Pembrolizumab (Keytruda) was granted a priority review by the FDA on May 25 for the treatment of patients who have undergone at least 2 courses of chemotherapy for recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.

http://www.targetedonc.com/news/pembrolizumab-granted-priority-review-by-the-fda-for-advanced-gastric-cancer

Epoetin Alfa Biosimilar Was Recommended for Approval by ODAC

The approval of a biologics license application for epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira, was recommended for approval by ODAC in a 14-1 vote on May 25.

http://www.targetedonc.com/news/epoetin-alfa-recommended-for-approval-by-odac

Nivolumab Granted FDA's Priority Review for Liver Cancer

Nivolumab (Opdivo) was granted a priority review designation by the FDA on May 26 for use as a treatment for patients with hepatocellular carcinoma following prior sorafenib (Nexavar), according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.

http://www.targetedonc.com/news/nivolumab-granted-fdas-priority-review-for-liver-cancer

KTE-C19 Granted a Priority Review by FDA for Non-Hodgkin Lymphoma

Axicabtagene ciloleucel (KTE-C19; axi-cel) was granted a priority review by the FDA on May 26 for transplant-ineligible patients with relapsed or refractory non-Hodgkin lymphoma, according to Kite Pharma, the developer of the CD19-directed chimeric antigen receptor (CAR) T-cell therapy.

http://www.targetedonc.com/news/ktec19-granted-priority-review-by-fda-for-nonhodgkin-lymphoma

Ceritinib Approved by the FDA for FrontlineALK+ NSCLC

Ceritinib (Zykadia) was approved by the FDA for the treatment of patients withALK-positive, metastatic NSCLC on May 26, according to Novartis, the manufacturer of the second-generation ALK inhibitor.

http://www.targetedonc.com/news/ceritinib-approved-by-the-fda-for-frontline-alk-nsclc