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Cancer Space Update: Label Expansions, Data Readouts in Focus

Zacks Equity Research

After a couple of quiet weeks, the cancer space witnessed some activity with FDA actions on label expansion and positive data readouts on major drugs from several companies. Meanwhile, a biosimilar for a blockbuster cancer drug received approval in Europe. A new drug was also granted approval for the treatment of leukemia.

Amgen, Inc.’s AMGN multiple myeloma drug, Kyprolis, received FDA nod to include overall survival (“OS”) data from the head-to-head ENDEAVOR study on its label. The first CAR-T therapy to receive approval, Novartis AG’s NVS Kymriah, got a boost as the FDA accepted a supplemental Biologics License Application (sBLA) seeking label expansion in diffuse large B-cell lymphoma (“DLBCL”). Moreover, AstraZeneca’s AZN Lynparza got the FDA nod for label expansion in metastatic breast cancer. Teva Pharmaceutical also announced approval of label expansion of its acute promyelocytic leukemia drug, Trisenox injection, in first-line setting, in combination with tretinoin.

Moreover, Amgen and partner Allergan AGN announced the approval of Mvasi, a biosimilar version of Roche’s RHHBY blockbuster cancer drug, Avastin in Europe.

Data readouts included encouraging data on Merck’s MRK Keytruda from confirmatory phase III lung cancer study and Exelixis, Inc.’s EXEL Cabometyx from phase III hepatocellular carcinoma study. Apart from these, BioLineRx Ltd BLRX also announced encouraging partial results from a phase IIa COMBAT study in pancreatic cancer on its lead pipeline candidate, BL-8040. Partial data from the study showed that BL-8040 as a monotherapy is safe and well- tolerated in patients with the given indication.

Let’s see the news in details.

Amgen’s Kyprolis Gets a Label Update; Avastin’s Biosimilar Approved: The FDA approved a regulatory application to include OS data from ENDEAVOR study on the label of Kyprolis. The FDA’s decision came much earlier than expected. It was initially expected in April. A similar application is under review in Europe. (Read more: Amgen Gets FDA Nod to Add ENDEAVOR Data on Kyprolis Label)

Amgen Inc. Price


Amgen Inc. Price | Amgen Inc. Quote

Novartis’s CAR-T therapy sBLA Accepted by the FDA: Novartis announced that the FDA has accepted and granted priority review to its sBLA seeking label expansion of its CAR-T therapy, Kymriah. A potential approval will expand the drug’s access to patients with relapsed or refractory DLBCL who are ineligible for or relapse after autologous stem cell transplant. (Read more: Novartis sBLA for CAR-T Therapy Kymriah Accepted by FDA)

Novartis AG Price


Novartis AG Price | Novartis AG Quote

AstraZeneca Announced Label Expansion of Lynparza in Breast Cancer: AstraZeneca’s PARP inhibiting ovarian cancer treatment, Lynparza, was granted label expansion in the United States to include metastatic breast cancer indication. Lynparza became the first PARP-inhibitor approved for treating metastatic breast cancer. The expanded label will certainly boost the drug’s prospects and give it an advantage over other two PARP inhibitors, which are only approved for ovarian cancer. (Read more: AstraZeneca's Lynparza Label Now Includes Breast Cancer)

Astrazeneca PLC Price


Astrazeneca PLC Price | Astrazeneca PLC Quote

Merck’s Keytruda Impressive in Phase III Lung Cancer Study: Merck shares got a boost on Jan 16, following the announcement that Keytruda in combination with Lilly’s Alimta and carboplatin achieved dual primary endpoints in a confirmatory phase III KEYNOTE-189 study. The study was evaluating the combination for the treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in first-line setting. The data was reported much earlier than anticipated (in February 2019). The combination was granted accelerated approval in May 2017 for the aforementioned indication. (Read more: Merck Strong on Confirmatory Phase III Lung Cancer Study)

Merck & Company, Inc. Price


Merck & Company, Inc. Price | Merck & Company, Inc. Quote

Exelixis’ Cabometyx Positive in Phase III Carcinoma Study: Exelixis, along with partner Ipsen, announced data from pivotal phase III CELESTIAL study of Cabometyx. Data from the study evaluating the drug in advanced hepatocellular carcinoma showed that it achieved significant OS benefit in patients who have received prior treatment. The median OS achieved by the drug was 10.2 months versus 8.2 months for placebo. (Read more: Exelixis, Ipsen Report Positive Results on Lead Cancer Drug)

Exelixis, Inc. Price


Exelixis, Inc. Price | Exelixis, Inc. Quote

Apart from these, Gilead announced this week that it has entered into a collaboration agreement with Pfizer to develop its CAR-T therapy, Yesacrta, in combination with the latter’s utomilumab, in patients with refractory large B-cell lymphoma.

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