On December 28, 2020 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that it has entered into an exclusive agreement with Inceptua Group ("Inceptua") for the distribution and commercialization of Apealea (paclitaxel micellar) in Europe (Press release, LSK BioPharma, DEC 28, 2020, View Source [SID1234573271]). Apealea has been authorized by European regulatory authorities for use in the European Economic Area in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased to announce our partnership with Inceptua to make Apealea (paclitaxel micellar) available to patients with ovarian cancer in Europe," said Alex Kim, Chief Executive Officer of Elevar Therapeutics. "Apealea is the only non-Cremophor based paclitaxel treatment approved in Europe for ovarian cancer, providing a treatment option with a higher paclitaxel dose and shorter infusion time without mandatory premedication versus Cremophor-based paclitaxel. Inceptua’s proven capabilities to develop and commercialize oncology and orphan treatments in Europe make them the ideal partner to accelerate access to Apealea in this important region. This agreement further propels progress for Apealea development and commercialization, an important step in Elevar’s strategy to optimize the value of its portfolio in global markets."

Under the terms of the agreement, Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe. These rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland).

"We are delighted to enter into this agreement with Elevar to commercialize Apealea (paclitaxel micellar) in Europe," said Stefan Fraenkel, Chief Executive Officer of Inceptua. "We believe there is great potential for Apealea to help patients with ovarian cancer who cannot tolerate paclitaxel formulated with Cremophor, and we look forward to leveraging our established sales force, distribution networks, and market access capabilities to bring this important treatment to patients and healthcare providers throughout Europe."

Apealea (paclitaxel micellar) is a non-Cremophor based formulation of paclitaxel. It received marketing authorization from the European Commission in 2018, which was the first approval in Europe for a non-Cremophor EL paclitaxel in ovarian cancer and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

About Ovarian Cancer

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs 1. Globally, it is the third most common cancer among women and has the highest mortality rate 2,3. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly 4,5. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis 6.

About Apealea (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Cremophor EL, is a toxic formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer.

On December 28, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on November 4, 2020, for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib) for the treatment of BRCA-mutated castrate-resistant prostate cancer with distant metastasis (mCRPC) (Press release, Chugai, DEC 28, 2020, View Source [SID1234573270]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic of olaparib for prostate cancer," said Dr. Osamu Okuda, Chugai’s President and COO. "In addition to ovarian cancer, the significance of detecting BRCA1/2 alterations and selecting the appropriate treatment for prostate cancer has become apparent. Through FoundationOne CDx Cancer Genomic Profile, we are committed to promoting the appropriate use of comprehensive genomic profiling to ensure that proper treatment will be provided to patients who may benefit from olaparib."

The approval aims to expand FoundationOne CDx Cancer Genomic Profile for use as a companion diagnostic to identify prostate cancer patients with BRCA1/2 alterations who could benefit from the treatment with olaparib whose disease progressed after treatment with enzalutamide or abiraterone by detecting BRCA1/2 gene alterations. The efficacy and safety of olaparib in mCRPC patients with BRCA1/2 alterations were investigated in the Phase III PROfound study and AstraZeneca K.K. received approval from the MHLW on December 25. Olaparib is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and MSD (Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., in the US and Canada).

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About BRCA alterations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.1-4

Trademarks used or mentioned in this release are protected by laws.

On December 28, 2020 AstraZeneca and MSD reported that Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers (Press release, AstraZeneca, DEC 28, 2020, View Source [SID1234573268]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The three approvals authorise Lynparza for: maintenance treatment after 1st-line chemotherapy containing bevacizumab (genetical recombination) for patients with homologous recombination repair deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castrate-resistant prostate cancer with distant metastasis (mCRPC); and as maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.

The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the PAOLA-1, PROfound and POLO Phase III trials, which each were published in The New England Journal of Medicine.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "These three approvals allow patients in Japan to be treated with Lynparza, a targeted treatment personalised to their specific biomarkers. They further underline the critical importance of biomarker testing at diagnosis, which helps physicians determine a course of treatment tailored to individual patients to substantially delay disease progression."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "For patients in Japan diagnosed with each of these types of cancer there are very few treatment options. Approvals for treatments such as Lynparza, the first PARP inhibitor to be approved in these specific types of metastatic castration-resistant prostate cancer and metastatic pancreatic cancer in Japan, enable us to advance this evolving era of personalised medicine and change how these cancers are treated."

Lynparza in ovarian cancer
The approval as 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer is based on a biomarker subgroup analysis of the PAOLA-1 Phase III trial which showed Lynparza, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone, for patients with HRD-positive advanced ovarian cancer.

In 2020, nearly 11,000 women in Japan were diagnosed with ovarian cancer, with more than 5,000 women dying of the disease.1 One in two women with advanced ovarian cancer has an HRD-positive tumour.2,3

Lynparza in prostate cancer
The approval for the treatment of BRCAm mCRPC is based on a subgroup analysis of the PROfound Phase III trial which showed Lynparza demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations. Lynparza is the first and only PARP inhibitor approved in Japan in advanced prostate cancer.

Prostate cancer is the third most common type of cancer in Japan and in 2020, accounted for over 100,000 new cases.1 With limited treatment options, the average survival for men with mCRPC is only 9-13 months.8 Approximately 12% of men with mCRPC have a BRCA mutation,5 a subgroup of patients with a particularly poor prognosis.

Lynparza in pancreatic cancer
The approval for BRCAm metastatic pancreatic cancer is based on the results of the POLO Phase III trial which showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in PFS versus placebo in patients with germline BRCAm metastatic pancreatic cancer. Lynparza is the first and only PARP inhibitor approved in this disease.

Pancreatic cancer has one of the lowest survival rates of the most common cancers and in Japan was responsible for almost 40,000 deaths in 2020 – the fourth most common cause of cancer death.1,5 Japan has the third-highest rate of pancreatic cancer in the world with 44,000 new cases diagnosed in 2020.1,6 Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.7

AstraZeneca and MSD are exploring additional trials in advanced prostate cancer including the ongoing PROpel Phase III trial testing Lynparza as a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021. AstraZeneca is exploring additional trials in advanced ovarian cancer, including the DUO-O Phase III trial testing Imfinzi (durvalumab) in combination with chemotherapy and bevacizumab, followed by maintenance treatment with Imfinzi, bevacizumab, and Lynparza in newly diagnosed advanced ovarian cancer patients.

PAOLA-1
PAOLA-1 is a double-blinded Phase III trial testing the efficacy and safety of Lynparza added to standard-of-care bevacizumab versus bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS in the overall trial population.

The PAOLA-1 Phase III trial showed that Lynparza, in combination with bevacizumab maintenance treatment, reduced the risk of disease progression or death by 67% (based on a hazard ratio [HR] of 0.33, 95% confidence interval [CI] 0.25-0.45). The addition of Lynparza improved PFS to a median of 37.2 months versus 17.7 with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

PROfound
PROfound is a prospective, multicentre, randomised, open-label, Phase III trial testing the efficacy and safety of Lynparza versus enzalutamide or abiraterone in patients with mCRPC who have progressed on prior treatment that included new hormonal agents (abiraterone or enzalutamide) and have a qualifying tumour mutation in BRCA1/2, ATM or one of 12 other genes involved in the homologous recombination repair (HRR) pathway.

The trial was designed to analyse patients with HRR gene mutations in two cohorts: the primary endpoint was rPFS in those with mutations in BRCA1/2 or ATM genes and then, if Lynparza showed clinical benefit, a formal analysis was performed of the overall trial population of patients with HRR gene mutations (BRCA1/2, ATM, CDK12 and 11 other HRR gene mutations). AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of rPFS.

The subgroup analysis from the PROfound Phase III trial showed Lynparza reduced the risk of disease progression or death by 78% (based on a HR of 0.22, 95% CI, 0.15-0.32; nominal p<0.0001) and improved rPFS to a median of 9.8 months versus 3.0 with enzalutamide or abiraterone in men with mCRPC with BRCA1/2 mutations. Lynparza reduced the risk of death by 37% (based on a HR of 0.63, 95% CI 0.42-0.95) with median OS of 20.1 months versus 14.4 with enzalutamide or abiraterone.

POLO
POLO is a randomised, double-blinded, placebo-controlled, multi-centre Phase III trial of Lynparza tablets (300mg twice daily) as maintenance monotherapy versus placebo. The trial randomised 154 patients with germline BRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy. Patients were randomised (3:2) to receive Lynparza or placebo until disease progression. The primary endpoint was PFS and key secondary endpoints included OS, time to second disease progression, overall response rate and health-related quality of life.

Data from the Phase III POLO trial showed Lynparza nearly doubled the time patients with germline BRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 on placebo and reduced the risk of disease progression or death by 47% (based on a HR of 0.53, 95% CI 0.35-0.82; p=0.004).

BRCA
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes are mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.8-11

HRD
HRD, which defines a subgroup of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.12

Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR, such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US and EU as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US, the EU and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for HRR gene-mutated metastatic castration-resistant prostate cancer (BRCAm and other HRR gene mutations) and in the EU for BRCAm metastatic castration-resistant prostate cancer. Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 40,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On December 27, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that BYVASDA (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of adult recurrent glioblastoma (GBM, the most common malignant primary brain tumor), which is the third approved indication of BYVASDA in China (Press release, Innovent Biologics, DEC 27, 2020, View Source [SID1234573266]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BYVASDA was firstly approved by China NMPA on June 17, 2020. Previous approved indications of BYVASDA include advanced non-small cell lung cancer and metastatic colorectal cancer.

In recent years, the cancer burden in China has been continuously increasing. According to the report of Cancer Today from the World Health Organization’s International Agency for Cancer Research, there were 4.285 million newly diagnosed cancer patients and 2.865 million deaths from cancer in China in 2018. Among the malignant tumors, glioblastoma is the most frequent and aggressive type of primary malignant brain tumor in adults, characterized by high morbidity, high recurrence rate, high mortality rate and low cure rate. Current major treatment regimens for glioblastoma include surgical resection, radiotherapy, and chemotherapy. The median survival time is only 12 to 15 months which have no significant change over the past decade. Therefore, more new therapeutic methods are urgently needed in glioblastoma patients.

Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer, and in China it was approved for the treatment of patients with advanced non-small cell lung cancer, metastatic colorectal cancer and adult recurrent glioblastoma. The efficacy and safety of bevacizumab have been well recognized worldwide. However, there still remains huge unmet clinical demand for bevacizumab treatment in China, as many ordinary Chinese patients cannot afford for original drugs. BYVASDA is an anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody and a bevacizumab biosimilar independently developed by Innovent. The launch of BYVASDA has provided Chinese patients with high quality and relatively more affordable bevacizumab biosimilar injection.

Dr. Hui Zhou, Vice President of Oncology Strategy and Medical Sciences of Innovent, stated: "Glioblastoma is the third approved indication of BYVASDA in China following advanced non-small cell lung cancer and metastatic colorectal cancer. The prognosis of glioblastoma patients is still poor even after standard postoperative radiotherapy and chemotherapy. Almost all patients will relapse after first-line treatment, with low five-year survival rate. We hope to bring this high-quality and cost-saving drug to more patients in need in China. In January 2020, Innovent out-licensed the commercial rights of BYVASDA in the United States and Canada to Coherus BioSciences, a leading biosimilar company, demonstrated an international recognition of the quality of BYVASDA. We are looking forward to working together to make BYVASDA benefit more patients globally."

About Recurrent Glioblastoma

Glioblastoma is the most common malignant primary brain tumor, representing approximately 57% of all gliomas and 48% of all primary malignant central nervous system (CNS) tumors, with an incidence of 3.2 per 100,000 populations. The current standard treatment regimen for primary glioblastoma includes a combination of surgical resection, radiotherapy, and chemotherapy. Due to the aggressive nature, almost all glioblastomas recur after initial therapy. In 2009, Bevacizumab was approved by the US Food and Drug Administration for recurrent glioblastoma.

About BYVASDA

BYVASDA is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.

On December 27, 2020 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) (Press release, InnoCare Pharma, DEC 27, 2020, View Source [SID1234573265]). Both new drug applications (NDAs) were previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I would like to thank our entire team at InnoCare for their hard work and contributions," said Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare. "This approval marks the maturation of InnoCare from a clinical to a commercial stage company.

"The approval of orelabrutinib would not have been possible without the strong support from our partners, physicians, experts and patients who participated in a series of clinical trials," said Dr. Cui. "Science drives innovation for the benefit of patients. From the initial R&D to patients, orelabrutinib has gone through an extraordinary journey. Treatment with orelabrutinib has demonstrated clear benefit for patients. We remain highly focused on the development of additional high-quality innovative drugs that can address unmet needs."

Orelabrutinib is a BTK inhibitor developed by InnoCare for the treatment of cancer and autoimmune diseases.

"Compared with other BTK inhibitors, orelabrutinib shows a higher complete response (CR) rate in the treatment of relapsed/refractory (R/R) CLL/SLL patients, and we expect even deeper responses with a longer treatment of patients with orelabrutinib," said Jianyong Li, M.D., Professor and Director of the Department of Hematology and Director of the Pukou CLL Center at the First Affiliated Hospital of Nanjing Medical University. "We believe that the approval of orelabrutinib will provide a safe and effective new treatment solution for lymphoma patients in China."

"Data from trials with orelabrutinib have shown sustained efficacy in the treatment of R/R MCL patients," said Jun Zhu, M.D., Ph.D., Professor and Director of the Department of Internal Medicine and Lymphoma, Peking University Cancer Hospital. "We believe the improved safety profile resulting from high selectivity and the convenience of daily oral administration will help make orelabrutinib a favorable treatment option for patients of B-cell malignancies."

China represents a large pharmaceutical market. The development of novel drugs requires focused drug discovery efforts, world-class research and development capabilities, state-of-the-art clinical research and significant capital investment.

"Continuous breakthroughs in life science technology are the foundation for the sustainable development of China’s healthcare industry in the future," said Professor Yigong Shi, the co-founder and President of the Science Advisory Board (SAB) of InnoCare. "To promote the research and development of innovative drugs such as orelabrutinib, cutting-edge science is essential, and it is equally critical to integrate collaborations among industry, academia, research institutions and hospitals. By doing so, R&D can keep up with rapidly evolving market needs. At present, although science and technology continue to evolve, we are still far from defeating malignant tumors and autoimmune diseases. I sincerely believe that more innovative companies will emerge in China and make greater contributions to the development of China’s healthcare system."

Lymphoma is a malignant tumor that originates from the lymphoid hematopoietic system. Relevant data show that lymphoma is one of the malignant tumors with the fastest growth of incidence rate and one of the top ten malignant tumors with the highest mortality rate in China. Every year, approximately 93,000 people are newly diagnosed with lymphoma, and more than 50,000 people die from it1. BTK is a key kinase of the B cell receptor (BCR) signaling pathway and an important regulator of B cell proliferation and survival mainly in non-Hodgkin’s lymphoma (NHL). BTK inhibitors can block BCR-induced BTK activation and downstream signaling pathways, thereby inhibiting the growth of B-cell tumors and promoting cell apoptosis.

Orelabrutinib is a highly selective and novel BTK inhibitor developed by InnoCare that can avoid off-target-related adverse events with improved safety and efficacy.