Propanc Biopharma Presents 100 Years of Clinical Evidence for “Novel” Enzyme Therapeutic Approach to Treat Cancer

On May 26, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that 100 years of clinical evidence supporting the use of proenzymes as a new therapeutic approach to treat cancer can be considered ‘compelling’ (Press release, Propanc, MAY 26, 2022, View Source [SID1234615114]). Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, has researched the effects of proenzymes against cancer for over 15 years and first came across the technology in his search to extend the life of several late-stage patients suffering from malignant solid tumors in the mid 2000’s. It was Professor John Beard from Edinburgh University who first proposed that pancreatic enzymes represent the body’s primary defense against cancer and would be useful as a cancer treatment. Since then, several scientists have endorsed Beard’s hypothesis with encouraging data from patient treatment.

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In 1902, in an article published in The Lancet, Professor Beard proposed that the answer to questions about the origin of cancer could be found in the field of embryology. Professor Beard tested his theory in a mouse model of cancer. After injections of commercially available pancreatic enzyme trypsin, the tumor in a treated mouse was much smaller than that in an untreated control. Over several years, a number of physicians in the UK and US injected enzyme preparations with some remarkable success stories. As a result, the physicians began writing letters to the editor summarizing their clinical cases, such as Medical Record in the early 1900’s.

For example, Dr Campbell wrote about a 56-year-old male with a malignant left tonsil the size of a hen’s egg, experiencing left facial paralysis and constant pain. After periodic injections for a month, the infiltrations in the tongue and tonsil were greatly decreased, pain free and felt well. A second example, Dr Oldfield, reported a 65-year-old male with an abdominal tumor with secondary metastases in the stomach, full of solid tumor and in great pain. After daily injections for 3 months, the patient was reported to eat and sleep well, returned to a normal weight. Dr Outfield concluded that "No-one…can doubt the immense improvement that has taken place." However, mixed results in the early stages of treatment were observed and attributed by Beard to the wide variation in the quality of enzymes of available enzymes at the time.

Over the years, there have been further clinical cases investigated into the use of enzymes as a way to treat cancer. Of particular note was the work undertaken by molecular biologist from Bucknell University, Dr Josef Novak and a retired Czech oncologist, Dr Frantisek Trnka. Drs Novak and Trnka undertook extensive laboratory work in the late ‘90s and 2000s, publishing their work in the journal Anticancer Research in the mid 2000s, where they first proposed that the enzyme extracts as recommended by Beard, must be used in the "proenzyme" form to ensure their selective activation at the tumor site. They also undertook clinical research, administering a proenzyme treatment via a suppository formulation to 20 late-stage cancer patients, with a range of malignancies, of which 10 survived, ranging from 8 months to 10 years, with minimal, or non-existent side effects normally seen with current standard therapies. The conclusion of Drs Novak and Trnka from this work was the discovery "that proenzyme therapy mandated first by John Beard nearly one hundred years ago, shows remarkable selective effects that result in growth inhibition of tumor cells with metastatic potential."

As a result of the clinical evidence observed throughout the years, Dr Kenyon decided to undertake his own investigation motivated by the condition of a number of late-stage cancer patients he treated in his clinical practice at The Dove Clinic, in Hampshire, UK. Consequently, the clinical efficacy of a suppository formulation containing pancreatic proenzymes was evaluated in the context of a UK Pharmaceuticals Special Scheme and results published in a peer reviewed journal, Scientific Reports. Clinical effects were studied in 46 patients with advanced metastatic cancers of different origin (prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel cancer and melanoma) after treatment with a rectal formulation consisting of pancreatic proenzymes trypsinogen and chymotrypsinogen.

Dr Kenyon concluded that no severe or serious adverse events related to the rectal administration were observed. Patients did not experience any hematological side effects as typically seen with classical chemotherapy regimens. No allergic reactions after rectal administration of suppositories were also observed. In order to assess the therapeutic activity of rectal administration, overall survival of patients under treatment was compared to the life expectancy assigned to a patient prior to treatment start. Nineteen (19) from 46 patients (41.3%) with advanced malignant diseases, most of them suffering from metastases, had a survival time significantly longer than their expected, in fact, for the whole set of cancer types, mean survival (9.0 months) was significantly higher than mean life expectancy (5.6 months). Although the number of patients per cancer indication was naturally quite low, 3 out of 8 patients with prostate cancer and 5 out of 11 patients with gastrointestinal cancers appeared to particularly benefit from the treatment with the proenzyme suppositories.

"As a result of my research over the last 15 years, as well as the clinical evidence over the last 100 years, proenzyme therapy can have a meaningful and long-lasting clinical benefit on patients suffering from solid tumors, but without the side effects associated with standard therapies, which is simply compelling," said Dr Kenyon. "Since the pioneering work undertaken by Professor John Beard and his medical colleagues, in the early 1900’s, their approach was ahead of their time, but since then, our understanding of tumor cell biology means we have elucidated how the activated enzymes works against solid tumors and in particular, cancer stem cells, optimized the formulation and its clinical effects, and developed a product candidate to pharmaceutical standard which can be administered by I.V. injection to maximize the exposure at the tumor site. My scientific and clinical research team at Propanc Biopharma are preparing to take our lead product candidate, PRP, into a world first, Phase I, First-In-Human study in advanced cancer patients suffering from solid tumors. The 100-year history of enzyme therapy gives me confidence we are on the right pathway with an exciting approach for the treatment and prevention of metastatic cancer from solid tumors, which is the main cause of patient death for sufferers."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

FibroGen to Present at Jefferies Healthcare Conference

On May 26, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 9 at 1:30pm EDT (Press release, FibroGen, MAY 26, 2022, View Source [SID1234615113]).

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A live audio webcast of the event will be available on the "Events & Presentations" section of the FibroGen Investors webpage at www.fibrogen.com. A replay will be available for approximately 30 days.

AFFIMED TO PRESENT AT THE 2022 JEFFERIES HEALTHCARE CONFERENCE

On May 26, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Executive Officer, Dr. Adi Hoess, will present at the 2022 Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 1:00 p.m. Eastern Daylight Time / 19:00 Central European Time (Press release, Affimed, MAY 26, 2022, View Source [SID1234615112]).

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A live webcast of the presentation will be accessible on Affimed’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

For more information on the conference or to schedule a one-on-one meeting with Affimed’s management, please contact Jefferies or Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.

Data from Incyte’s Robust and Progressing Oncology Portfolio to be Presented at 2022 EHA Annual Meeting

On 26, 2022 Incyte (Nasdaq:INCY) reported that multiple abstracts featuring data from its oncology portfolio will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 (EHA2022) Congress (June 9-17; virtual and in Vienna) (Press release, Incyte, MAY 26, 2022, View Source [SID1234615111]).

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"We are committed to advancing science that can lead to solutions for patients with serious unmet medical needs, including those with cancer"

"We are committed to advancing science that can lead to solutions for patients with serious unmet medical needs, including those with cancer," said Steven Stein, M.D., Chief Medical Officer, Incyte. "For that reason, we look forward to convening with the oncology community and presenting data from across our portfolio, including both Incyte-led and partnered programs."

Key abstracts accepted by EHA (Free EHA Whitepaper) include:

Oral Presentation

Long-term Efficacy and Safety Results from an Ongoing Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #S286. Session: Transfusion and Autoimmune Hemolytic Anemia. Session Time: Friday, June 10, 11:30 a.m. – 12:45 p.m.)

Poster Presentations

A Real-World Evaluation of the Association Between Elevated Blood Counts and Thrombotic Events in Polycythemia Vera: An Analysis of Data from the Reveal Study (Abstract #P1062. Session: Myeloproliferative neoplasms – Clinical)

Does Early Intervention in Myelofibrosis Impact Outcomes? A Pooled Analysis of the COMFORT 1 and 2 Studies (Abstract #P1037. Session: Myeloproliferative neoplasms – Clinical)

Ruxolitinib Demonstrates a Greater Corticosteroid-Sparing Effect than Best Available Therapy in Patients with Corticosteroid-Refractory/Dependent Chronic Graft-Vs-Host Disease1 (Abstract #P1389. Session: Stem cell transplantation – Clinical)

Real-World Safety of Ruxolitinib in Patients with Intermediate or High Risk of Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis in China1 (Abstract #P1047. Session: Myeloproliferative neoplasms – Clinical)

Efficacy and Safety of Parsaclisib-Ruxolitinib Combination Therapy in Myelofibrosis Patients with Low vs Higher Baseline Platelet Count: A Subgroup Analysis of Data from a Phase 2 Study (Abstract #P1063. Session: Myeloproliferative neoplasms – Clinical)

A Phase 1 Study Evaluating Safety and Efficacy of Parsaclisib in Combination with Bendamustine + Obinutuzumab in Patients with Relapsed or Refractory Follicular Lymphoma (CITADEL-102) (Abstract #P1104. Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical)

A Phase 1 Study of Parsaclisib in Combination with Investigator Choice of Rituximab, Bendamustine + Rituximab, or Ibrutinib in Patients with Previously Treated B-Cell Lymphoma (CITADEL-112): Preliminary Safety Results (Abstract #P1102. Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical)

inMIND: A Phase 3 Study of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo Plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) (Abstract #P1103. Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical)

Real-Life Effectiveness and Safety Outcomes of Ponatinib Treatment in Patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (PH+ALL): 5-Year-Data from a Belgian Registry (Abstract #P699. Session: Chronic myeloid leukemia – Clinical)

Dose Modification Dynamics of Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) from the PACE and OPTIC Trials2 (Abstract #P707. Session: Chronic myeloid leukemia – Clinical)

All (e)Poster presentations will be made available as of Friday, June 10, 2022, at 3:00 a.m. EST and will be accessible for on-demand viewing until Monday, August 15, 2022, on the Congress platform. For full session details and data presentation listings, please see the EHA (Free EHA Whitepaper)2022 online program (View Source).

About Ruxolitinib (Jakafi)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF, for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older and for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi (ruxolitinib) outside the U.S. Jakafi is a registered trademark of Incyte. Jakavi is a registered trademark of Novartis AG in countries outside the U.S.

About Tafasitamab (Monjuvi / Minjuvi)
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Full approval for this indication may be contingent upon results in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S. and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

About Ponatinib (Iclusig) Tablets
Ponatinib (Iclusig) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

About Parsaclisib
Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in non-Hodgkin lymphomas and autoimmune hemolytic anemia, and in combination with ruxolitinib and tafasitamab for myelofibrosis and non-Hodgkin lymphomas, respectively.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

Clinical Data Demonstrating Promising Antitumor Activity with Zanidatamab in 1L
Setting of HER2-Positive Breast and Gastroesophageal Cancers to be Presented at ASCO 2022

On May 26, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported new clinical data for the HER2-targeted bispecific antibody zanidatamab in both HER2-positive breast cancer and gastric/gastroesophageal junction adenocarcinoma (Press release, Zymeworks, MAY 26, 2022, View Source [SID1234615109]). The data are being presented in two separate poster sessions at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting June 3-7, 2022 in Chicago, IL.

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"These encouraging new data sets presented at ASCO (Free ASCO Whitepaper) provide further validation of zanidatamab’s potential in the treatment of advanced HER2-positive cancers and follow the release of other promising data in gastroesophageal and breast cancer in 2021," said Neil Josephson, M.D., Chief Medical Officer at Zymeworks. "These new data continue to demonstrate the potential for zanidatamab to be an important advancement in the treatment of a wide range of HER2-expressing cancers, including in first-line treatment regimens."

The presentations detailed below are available to conference registrants on the ASCO (Free ASCO Whitepaper) conference website as well as to the general public at www.zymeworks.com/publications.

Poster Session: Zanidatamab in Combination with Chemotherapy and Tislelizumab in HER2-Positive Gastric/Gastroesophageal Junction Cancer – Clinical Results – Saturday, June 4, 08:00-11:00 am CDT

Zanidatamab, a HER2-targeted bispecific antibody, in combination with chemotherapy and tislelizumab as first-line therapy for patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GJEC): Preliminary results from a Phase 1b/2 study

Presenter: Keun Wook Lee, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea

Over one million patients are diagnosed with gastric cancer every year worldwide, and it is the fourth most common cause of cancer-related deaths1. Human epidermal growth factor receptor 2 (HER2)-positive disease accounts for 15–25% of gastric cancers2. For these patients, trastuzumab in combination with chemotherapy is the global standard of care treatment but with an expected overall survival of less than 18 months, there remains a significant unmet need.

1
Globocan 2020. Available at: View Source Accessed April 2022

2
Nakamura Y, et al. Nat Rev Clin Oncol 2021;18:473–87

In 33 response-evaluable patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma treated with zanidatamab and tislelizumab in combination with the CAPOX chemotherapy regimen the cORR was 75.8% (25/33). The DCR was 100% (33/33) and duration of response (DOR) ranged from 2.1+ to 18.2+ months. Twenty patients (61%) remain on study at the time of data cut-off.

In addition, the data demonstrate that zanidatamab and tislelizumab in combination with the CAPOX chemotherapy is generally well tolerated, with the majority of treatment-related adverse events (TRAEs) considered mild to moderate in severity (Grade 1 or 2). The most common grade ≥ 3 TRAE was diarrhea, which was manageable in the outpatient setting; introduction of prophylactic loperamide reduced the incidence from 33% to 21%. Immune mediated adverse events occurred in 27% of patients, including ≥ Grade 3 events in 21% of patients and resulted in discontinuation of tislelizumab in 3 patients (9%). This manageable safety profile compares favorably to the current standard of care as well as to emerging treatments and is consistent with previous reports.3

This new data set further supports the launch of Zymeworks’ global Phase 3 study (HERIZON-GEA-01; NCT05152147), which is investigating zanidatamab in combination with chemotherapy with or without tislelizumab for first-line treatment of locally advanced, unresectable, or metastatic HER2-positive gastroesophageal adenocarcinoma. Zymeworks, along with its Asia-Pacific partner BeiGene, plan to enroll 714 patients at approximately 300 sites across 38 countries. Enrollment is expected to be completed by the end of 2023. The study design will be presented in a Trials in Progress poster (Poster ID: P-26) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain from June 29-July 2, 2022. The presentation will be available to conference registrants on the conference website as well as to the general public at www.zymeworks.com/publications at the time of presentation at the conference.

Poster Session: Zanidatamab in Combination with Docetaxel in HER2-Positive Breast Cancer – Clinical Results – Monday, June 6, 08:00-11:00 am CDT

Zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study

Presenter: Keun Seok Lee, National Cancer Center, Center for Breast Cancer, Goyang, Republic of Korea

Worldwide, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer deaths in women, with over 650,000 deaths in 20201,4. HER2-positive breast cancer accounts for approximately 20% of all breast cancers5,6,7. Though HER2-targeted agents have improved outcomes in HER2-positive breast cancer, most patients treated for advanced disease eventually relapse and develop resistant disease8,9.

In 21 response-evaluable patients with advanced HER2-positive breast cancer treated with zanidatamab and docetaxel the cORR was 90.5%, with 15 patients (78.9%) having an ongoing response at the time of the data cut. The median follow-up was 7.0 months (range 1.1-17.4 months) and the six-month progression-free survival rate was 95.2%.

3
Ku G, et al. Ann Oncol 2021;32:S1044

4
Bray F, et al. CA Cancer J Clin 2018; 68:394–424

5
Harris L, et al. J Clin Oncol 2007; 25(33)

6
Wolff AC, et al. Arch Pathol Lab Med 2007; 131(1):18–43

7
Giordano SH, et al. J Clin Oncol 2014;32(19):2078–99

8
Ayoub NM, et al. Breast Cancer 2019:11;53–69

9
Rier HN, et al. Oncologist 2017;22:901–9

The combination of zanidatamab and docetaxel had a manageable safety profile with the incidence of TRAEs consistent with standard of care therapy. The most common TRAEs were neutrophil count decreased (13 patients; 54.2%), diarrhea (13 patients; 54.2%), and anemia (nine patients; 37.5%), and the most common ≥ Grade 3 TRAEs were neutrophil count decreased (12 patients; 50.0%), diarrhea (3 patients; 12.5%), and white blood cell count decreased (2 patients; 8.3%).

"We will continue to support ongoing R&D efforts to generate and report robust data highlighting and reinforcing the potential applications of our therapeutics and technology platforms in the treatment of a wide range of diseases," said Kenneth Galbraith, Chair and CEO of Zymeworks. "We remain focused on exploring potential research and collaboration opportunities that can lead to a broader portfolio of innovative therapies for patients in need around the world with difficult-to-treat cancers."

Conference Call and Webcast

Zymeworks will host a conference call and webcast on Monday, June 6th at 4:30 pm ET to discuss the clinical data presented at ASCO (Free ASCO Whitepaper) and provide an overview on the clinical development strategy for zanidatamab. The event will be led by Kenneth Galbraith, Zymeworks’ Chair and CEO, and Neil Josephson, M.D., Zymeworks’ Chief Medical Officer. Members of Zymeworks’ executive team will be available to answer questions at the conclusion of the call.

Interested parties can access the live webcast via the Zymeworks’ website at View Source A recorded replay will be accessible after the event through the Zymeworks website.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.