Busy Month of Approvals: A Review of Oncology Drugs Approved in May in China and world market

The first half of 2020 will pass soon. Although foreign countries are still under the shadow of the COVID-19 pandemic, China’s situation is gradually stabilizing and improving through the concerted efforts of all to fight the pandemic. It is gratifying that there is no slacking in the approval of new anticancer drugs, whether in China or abroad. Many new drugs and therapies have been approved for marketing in May alone. Here is an overview of several representative important approvals in the oncology field for your reference.

The NMPA approved brentuximab vedotin for the treatment of lymphoma on May 14

May 14, 2020, Shanghai, China—Takeda China announced that its innovative targeted drug ADCETRIS (brentuximab vedotin for injection) was officially approved by the National Medical Products Administration of China (NMPA) to enter China, with the indication approved being the treatment of adult patients with CD30-positive relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or relapsed or refractory classical Hodgkin lymphoma (cHL).

Brentuximab vedotin comprises an anti-CD30 monoclonal antibody attached by a microtubule inhibiting cytotoxic agent, monomethyl auristatin E (MMAE), which can stably exist in the blood to precisely kill tumor cells that express CD30. The product is largely used in clinical trials and has sufficient real-world evidence and proven efficacy. Brentuximab vedotin has already been recommended as a standard therapeutic drug by the National Comprehensive Cancer Network (NCCN) Guidelines and also included in the scope of clinical choice by the Chinese Society of Clinical Oncology (CSCO) Guidelines.

The approval of brentuximab vedotin in China is based on the data from clinical studies SG035-0004, SG035-0003 and C25007. In the SG-035-0004 study, among 58 patients with relapsed or refractory sALCL, tumor reduction was seen in 97%, and their five-year survival rate increased to 60%. In the SG-035-0003 study, among patients with relapsed or refractory cHL, tumor reduction was seen in 94%, with the median overall survival (OS) increasing from a historical 27.6 months to 40.5 months. The C25007 study is a study of patients (n=60) with relapsed or refractory cHL who had received chemotherapy at least once and were not suitable for stem cell transplantation (SCT) or multidrug chemotherapy when they began to receive treatment with brentuximab vedotin. In this study, the objective remission rate (ORR) for the subjects was 50% (95% CI, 37: 63%)

For decades, treatment options for patients in China with sALCL or cHL have been very limited. Brentuximab vedotin, an anti-CD30 innovative antibody-drug conjugate (ADC), can fill the gap in the field of CD30-positive lymphoma therapeutics in China.

The marketing application for another Chinese-produced anti-PD-1 monoclonal antibody was accepted by the NMPA on May 26!

Sino Biopharmaceutical announced on May 26 that the marketing application for the new drug Annike (generic name: penpulimab; R&D code: AK105), an anti-PD-1 monoclonal antibody jointly developed and commercialized by the company and Akeso, was accepted by the NMPA to treat patients with relapsed or refractory cHL. Up to now, AK105 will be the tenth immune drug accepted following the approval of nine anti-PD-1/PD-L1 monoclonal antibodies in China. If you are looking for health supplies online, then Pharmasources would be your best choice for there are many companies on Pharmasources who are professional in making medicine.

The FDA approved MET inhibitor capmatinib on May 6 for the treatment of lung cancer

As an oral, highly selective oral small-molecule inhibitor of MET, capmatinib was approved by the U.S. FDA for marketing on May 6, 2020. Most importantly, capmatinib (Tabrecta, INC280) is the first FDA-approved targeted drug for patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated NSCLC.

Capmatinib attracted much attention and was quite impressive at the AACR Virtual Annual Meeting 2020 as a next-generation MET-targeted drug.

The FDA approved the first therapy for lung and thyroid cancers with RET gene mutations—Selpercatinib on May 8

The FDA granted accelerated approval to Retevmo (selpercatinib) on May 8, 2020 for three types of tumors (NSCLC, medullary thyroid cancer, and other types of thyroid cancer). Selpercatinib is the first FDA-approved highly selective RET kinase inhibitor.

The FDA approved the pomalidomide for the treatment of Kaposi sarcoma on May 14

On May 14, the FDA approved the expanded indication of pomalidomide for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in adult patients with Kaposi sarcoma who are HIV-negative. This approval was based on the results of an open-label, single-arm clinical trial (12-C-0047), which enrolled 28 patients (18 HIV-positive, 10 HIV-negative) who received pomalidomide (5mg, qd, d1-21, 28-day cycles), until disease progression or unacceptable toxicity. The primary endpoint of the study was overall response rate (ORR). According to the results, in HIV-positive patients, the ORR was 67%, and the median DOR was 12.5 months; in HIV-negative patients, the ORR was 80%, and the median DOR was 10.5 months.

The FDA approved the first fourth-line therapeutic drug for advanced gastrointestinal stromal tumor (GIST): ripretinib on May 15

Targeted therapy is the primary treatment means for unresectable or recurrent metastatic GIST. However, after the progress of third-line treatments, most R&D of fourth-line therapeutics failed. Encouragingly, the FDA approved the first fourth-line new therapeutic drug for GIST—ripretinib on May 15, to solve the dilemma of no drug available to GIST patients whose disease progresses after third-line treatment.

On May 15, the FDA approved rucaparib, the first drug for patients with BRCA mutation-associated metastatic castration-resistant prostate cancer

The FDA granted accelerated approval to the expanded indication of rucaparib on May 15 for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and taxane-based chemotherapy.

Rubraca is an oral, small-molecule inhibitor of PARP1, PARP2 and PARP3. This approval was based on the study data of TRITON2 that assessed the ORR and DOR in 62 patients with measurable disease. According to the results, the ORR was 44%, the median DOR was not evaluable, and the range of DOR was 1.7 to 24+ months.

On May 20, the FDA approved Lynparza (olaparib) for patients with homologous recombination repair (HRR) gene-mutated mCRPC

This approval was based on PROfound, a prospective, multicenter, randomized, open-label, phase III clinical trial testing the efficacy and safety of olaparib in patients diagnosed with mCRPC who are resistant to new endocrine therapies such as enzalutamide or abiraterone. The tissue gene mutation situation of all those patients was detected via NGS, mainly including the DNA HRR deficiency-related genes, such as BRCA1/2, ATM, and CDK12. Recruited subjects were divided into Cohort A (patients with BRCA1/2 or ATM mutations) and Cohort B (patients with 12 other genes involved in the HRR pathway).

The FDA approved atezolizumab in combination with bevacizumab as a first-line immunotherapy for hepatocellular carcinoma (HCC) on May 29

On May 29, the FDA approved atezolizumab in combination with bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy, making it the first and currently the only first-line immunotherapy for HCC.

Besides the above anticancer drugs approved, there were many new anticancer therapies approved in May, which will not be detailed here. With medical research going deeper, more and more new drugs will be developed and marketed soon, and more cancers are becoming chronic diseases.

References:

1. NCCN Clinical Practice Guidelines in Oncology: Hodgkin Lymphoma (Version 1.2020)；

2. NCCN Clinical Practice Guidelines in Oncology: T-Cell Lymphomas (Version 1.2020)；

3.Pro, B., et al. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood vol. 130,25 (2017): 2709-2717；

4.Younes, A., et al. Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients With Relapsed or Refractory Hodgkin's Lymphoma. Journal of Clinical Oncology 2012 30:18, 2183-2189；

5.Chen R., et al. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood 2016; 128 (12): 1562–1566；

6.Canadian Agency for Drugs and Technologies in Health. Brentuximab (Adcetris) for Hodgkin Lymphoma – Resubmission. 2019；

7. FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion. Published May 8, 2020. https://bit.ly/3beo62M. Accessed Published May 8, 2020；

8. FDA approves ripretinib for advanced gastrointestinal stromal tumor. http://www.fda.gov/.

About the Author:

Xiaobin

Xiaobin holds a Master's degree in Pharmacy and currently work as a public health control staff. Navigating through the intricate and complex data each day and feeling a sense of insignificance of herself. While being happy to witness the golden time of the development of Chinese bio-pharmaceutical industry. Hope to learn and improve together with everyone.