On February 23, 2021 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and twelve months ended December 31, 2020 (Press release, Odonate Therapeutics, FEB 23, 2021, View Source [SID1234575486]).

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As of December 31, 2020, Odonate had $157.3 million in cash, compared to $180.5 million as of December 31, 2019. This decrease in cash resulted primarily from cash used in operating activities for the twelve months ended December 31, 2020 of $113.1 million, partially offset by the receipt of $87.4 million of net proceeds from Odonate’s September 2020 underwritten public offering. Odonate’s net loss for the three and twelve months ended December 31, 2020 was $32.3 million and $126.4 million, or $0.87 and $3.84 per share, respectively, compared to $27.9 million and $111.8 million, or $0.91 and $4.05 per share, respectively, for the same periods in 2019.

"Positive results of CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer, were recently presented at the 2020 San Antonio Breast Cancer Symposium," said Kevin Tang, Chief Executive Officer of Odonate. "We continue to plan to submit a New Drug Application for tesetaxel to the FDA in mid-2021."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer (MBC), tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in MBC, including a multinational, multicenter, randomized, Phase 3 study in patients with MBC, known as CONTESSA. Positive results of CONTESSA were presented at the 2020 San Antonio Breast Cancer Symposium in December.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on Day 1 of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of a 21-day cycle) in 685 patients randomized 1:1 with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)‑negative MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have been treated with endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

Positive results of CONTESSA were presented at the 2020 San Antonio Breast Cancer Symposium in December. The primary endpoint was met: median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for the approved dose of capecitabine alone, an improvement of 2.9 months. The risk of disease progression or death was reduced by 28.4% (hazard ratio=0.716 [95% confidence interval [CI]: 0.573‑0.895; p=0.003]). Neutropenia was the most common Grade ≥3 treatment‑emergent adverse event.

On February 23, 2021 The Board of Directors of BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported that it has resolved to issue 19,095,000 shares (the "New Shares") in a directed share issue to international and Swedish institutional investors, where 2,834,399 New Shares are issued based on the authorization granted by the Extraordinary General Meeting on 27 November 2020, and 16,260,601 New Shares are issued subject to the approval of an upcoming Extraordinary General Meeting to be held on 23 March 2021 (together the "Directed Share Issue") (Press release, BioInvent, FEB 23, 2021, View Source;approxim,c3293708 [SID1234575413]).

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The price for the New Shares is SEK 50.36 per share and corresponds to the 5-day volume weighted share price of BioInvent’s share, as traded on Nasdaq Stockholm.
Investors in the Directed Share Issue are a range of international and Swedish institutional investors.
Through the Directed Share Issue, BioInvent will receive proceeds amounting to approximately SEK 962 million (approximately USD 116 million) before transaction costs.
BioInvent changes the date for publication of the year-end report 2020 and the interim report for the fourth quarter of 2020 to Tuesday, February 23, 2021. The previously announced date for publication was February 25, 2021.
Comments from the CEO

"We are very pleased to carry out this successful share issue, proceeds from which will fund the continued transformation of BioInvent and expansion of our clinical programs. BioInvent has a strong clinical oncology pipeline thanks to our F.I.R.S.T technology platform, with four ongoing clinical trials of first-in-class antibodies with unique mechanisms of action. This capital injection enables us to accelerate and broaden our clinical development." said Martin Welschof, CEO of BioInvent.

"Assuming continued generation of positive data, we plan to in particular use the funds to prepare a pivotal clinical trial of our first-in-class anti-FcγRIIB antibody BI-1206 for the treatment of Non-Hodgkin’s Lymphoma, with the aim of receiving an accelerated regulatory pathway. We also expect to expand the clinical programs of BI-1206 in combination with Keytruda and the anti-TNFR2 antibody BI-1808 as monotherapy and in combination with Keytruda.

Investors in the Directed Share Issue are a range of international and Swedish institutional investors, including Redmile Group, LLC., Invus, HBM Healthcare Investments, The Fourth National Swedish Pension Fund, Swedbank Robur Fonder and Van Herk Investments. Upon completion, Redmile will become the largest shareholder in BioInvent representing approximately 16.8 per cent of the shares and votes in the company.

I would like to thank our existing investors for their continued support and am delighted to welcome new investors in BioInvent. I look forward to continuing to work with all our investors as we continue to advance our innovative treatments to improve patients’ lives."

The Directed Share Issue

The price for the New Shares is SEK 50.36 per share and corresponds to the 5-day volume weighted share price of BioInvent share, as traded on Nasdaq Stockholm. The price per share in the Directed Share Issue has been resolved by the Board of Directors in consultation with the Joint Global Coordinators, based on negotiations with the largest new investor. Through the Directed Share Issue, BioInvent will receive proceeds amounting to approximately SEK 962 million before transaction costs.

The Directed Share Issue consists of two separate tranches: the first tranche amounting to 2,834,399 New Shares based on the authorization granted by the Extraordinary General Meeting held on 27 November 2020 ("Tranche 1") and the second tranche of 16,260,601 New Shares which will be subject to the approval of the Extraordinary General Meeting to be held on 23 March 2021 ("Tranche 2"). Completion of Tranche 1 is not conditional upon completion of Tranche 2.

The first day of trading for the New Shares in Tranche 1 will be on or about 26 February 2021 Subject to the approval of the Extraordinary General Meeting, the first day of trading for the New Shares in Tranche 2 is expected to be on or about 30 March 2021.

Tranche 2 of the Directed Share Issue will be subject to a listing prospectus prior to shares being admitted to trading on Nasdaq Stockholm. The listing prospectus is expected to be approved by the Swedish Financial Supervisory Authority on or about 24 March 2021, i.e. before the shares in Tranche 2 are subject to trading.

The reasons for deviating from the shareholders’ preferential rights are to diversify the shareholder base in the Company amongst international and Swedish institutional investors and at the same time take advantage of the opportunity to raise capital in a time and cost-efficient manner. The Board of Directors’ assessment is that the price per share in the Directed Share Issue is in accordance with market conditions.

The Directed Share Issue will entail a dilution of approximately 32.7 per cent of the number of outstanding shares and votes in the Company after the Directed Share Issue. Through the Directed Share Issue, the number of outstanding shares and votes in the Company will increase from 39,376,096 to 42,210,495 through Tranche 1 and from 42,210,495 to 58,471,096 through Tranche 2. The share capital will increase from SEK 7,875,219.20 to SEK 8,442,099 through Tranche 1 and from SEK 8,442,099 to SEK 11,694,219.20 through Tranche 2.

The Directed Share Issue is subject to certain customary conditions of the placing agreement entered into by the Company with the Joint Global Coordinators in connection with the Directed Share Issue, mainly entailing that the placing agreement is not terminated prior to the delivery of the respective Tranches.

Background and reasons

The net proceeds from the Directed Issue are mainly intended for: (i) preparations towards a pivotal clinical trial with the aim of receiving an accelerated regulatory pathway for BI-1206 for the treatment of Non-Hodgkin’s Lymphoma assuming continued generation of positive data; (ii) progressing the clinical development of BI-1206 in its Phase I/II trial for the treatment of advanced solid tumors in combination with Keytruda (pembrolizumab). Assuming positive clinical data, the net proceeds may be used to broaden the clinical studies; (iii) progressing the clinical development of BI-1808, as monotherapy and in combination with Keytruda (pembrolizumab), for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). Assuming positive clinical data, the net proceeds may be used to broaden the clinical studies; (iv) developing BT-001, in partnership with Transgene, for the treatment of solid cancers. Assuming positive clinical data, the net proceeds may be used to broaden clinical studies; (v) advancing BI-1607 into clinical development for the treatment of solid cancers; and (vi) continued development of the Company’s prioritized preclinical projects with the aim to generate additional clinical programs.

Moreover, a strengthened financial position enables increased strategic flexibility and improved ability to negotiate with potential partners.

Lock-up undertakings and voting commitments

In connection with the Directed Share Issue, the Company has undertaken, subject to customary exceptions and the completion of the Directed Share Issue, to not issue additional shares for a period of 180 days as from launch of the Directed Share Issue. In addition, shareholding members of the Board of Directors and management of BioInvent have undertaken to not sell shares in the Company for a period of 90 days as from launch of the Directed Share Issue, subject to customary exceptions.

Shareholders together currently representing approximately 43 per cent of the shares and votes in the Company, have undertaken, or indicated an intention, to vote in favor of the EGM approval of Tranche 2.

Advisors

Van Lanschot Kempen Wealth Management N.V. (Kempen & Co) and Pareto Securities AB have been appointed as Joint Global Coordinators in connection with the Directed Share Issue. Mannheimer Swartling Advokatbyrå acts as legal counsel to the Company and Baker McKenzie acts as legal counsel to the Joint Global Coordinators.

On February 23, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that 21-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard of care chemotherapy in malignant pleural mesothelioma (MPM) (Press release, Targovax, FEB 23, 2021, View Source [SID1234575430]).

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The trial is an open label, exploratory phase I/II trial adding ONCOS-102 to standard of care (SoC) chemotherapy (pemetrexed/cisplatin) in first and second (and later) line MPM to assess safety, immune activation and clinical efficacy vs SoC only. In total, 31 patients have been treated in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and chemotherapy combination, and 11 patients in a control group receiving chemotherapy only. The 31 patients have now completed the 21-month follow-up. Immunological data and 12-month survival rate were reported in June 2020 (see link here), and 18-month survival follow-up in November 2020 (see link here).

At the 21-month follow-up, half of the patients in the first-line ONCOS-102-treated group of the randomized part of the trial were still alive, and mOS was not yet reached. Based on current survival data mOS will be 20.5 months or longer. For the first-line SoC-only control group mOS is 13.5 months, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "It is most encouraging that survival continues to track so well in the ONCOS-102-treated first line group. We have earlier seen and reported how ONCOS-102 drives profound remodeling of the tumor microenvironment. It is now becoming clear that this is translating into long-term survival benefit. The survival data also holds up well to the recently FDA-approved ipilimumab and nivolumab combination, confirming the relevance of immunotherapy in mesothelioma and strongly suggesting combining ONCOS-102 with checkpoint inhibition could further boost efficacy in this highly malignant and difficult-to-treat cancer."

On February 23, 2021 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2020. Below is a summary of business progress in 2020, financial performance for the year and the financial outlook for 2021 (Press release, Genmab, FEB 23, 2021, View Source [SID1234575455]). The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com/investors.

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Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2020 today, February 23, 2021 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join the call dial +1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 82034909.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

On February 23, 2021 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported fourth quarter and full year 2020 financial results (Press release, Epizyme, FEB 23, 2021, View Source [SID1234575471]).

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"Epizyme cemented its position as a leader in epigenetics in 2020, with back-to-back accelerated approvals for TAZVERIK, the first and only FDA-approved EZH2 inhibitor. Following the approvals, we quickly reached epithelioid sarcoma and follicular lymphoma patients in need, adapting our physician and patient outreach efforts to meet the unique challenges presented by the evolving COVID-19 pandemic," said Robert Bazemore, President and Chief Executive Officer of Epizyme. "While the resurgence of COVID-19 cases in the fourth quarter extended many of these challenges, the adoption of TAZVERIK in both ES and FL continued to expand, with net revenue increasing 31% in the fourth quarter from the third quarter. Importantly, our sales and medical affairs teams continue to make progress reaching and educating physicians, reflected in the more than 50% increase in new accounts prescribing TAZVERIK during the fourth quarter. In addition to launch execution, we are encouraged by our clinical progress throughout 2020, during which we achieved all trial milestones on or ahead of schedule. Armed with sufficient capital to support our planned commercial and clinical execution, we believe Epizyme is well-positioned for success in 2021 and beyond."

Recent Progress

Commercial Execution: TAZVERIK generated net product revenue in Epithelioid Sarcoma (ES) and Follicular Lymphoma (FL) of $4.5 million in the fourth quarter and $11.5 million for the full year 2020. Epizyme reported a month-over-month increase in new prescriptions for TAZVERIK throughout the fourth quarter, despite the resurgence of COVID-19 cases that continued to negatively impact ES and FL patient visits to physicians, new patient starts across all lines of treatment as well as the ability of our field-based teams to fully access ES and FL prescribers. New accounts prescribing increased 50%, compared to the third quarter, including broader adoption among community practices.
NCCN Clinical Practice Guidelines Update Supports TAZVERIK: In February 2021, the NCCN Clinical Practice Guidelines in Oncology were amended to recommend TAZVERIK for relapsed/refractory FL patients with no satisfactory treatment options and whose EZH2 status is unknown. This revised recommendation reinforces the lack of requirement for EZH2 testing in the decision to prescribe TAZVERIK, consistent with the current TAZVERIK label and Epizyme’s physician education efforts.
ES and FL Confirmatory Trials: The safety run-in portions of both the ES and FL confirmatory trials with TAZVERIK are both fully enrolled and the efficacy expansion portions of both trials remain on track for initiation in early 2021. The ES confirmatory trial is evaluating TAZVERIK in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES. The FL confirmatory trial is evaluating TAZVERIK in combination with "R2" (Revlimid plus Rituxan) compared with R2 plus placebo in the second-line treatment setting in patients with FL.
Tazemetostat Program Expansion: Progress around the clinical development of tazemetostat to investigate therapeutic potential in earlier lines of therapy for FL and opportunities in new solid tumor indications, including prostate cancer, continues. Patient enrollment also continues in several collaborative studies, including the Lymphoma Study Association (LYSA) trial in front-line Diffuse Large B-cell Lymphoma (DLBCL) and FL, and in investigator sponsored trials.
Presented Four Posters from the FL Development Program at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, including: tazemetostat versus PI3-Kinases in patients with relapsed/refractory follicular lymphoma, tazemetostat or placebo plus lenalidomide and rituximab in patients with relapsed/refractory follicular lymphoma, single-agent tazemetostat as third-line therapy in patients with relapsed or refractory follicular lymphoma to identify predictors of response and tazemetostat in combination with rituximab for the treatment of relapsed or refractory follicular lymphoma.
Leadership Update: In February 2021, Dr. Shefali Agarwal was promoted to Executive Vice President and Chief Medical and Development Officer of Epizyme. This move expands Dr. Agarwal’s breadth of leadership in all stages of development and in the regulatory advancement of tazemetostat and Epizyme’s early clinical-stage and emerging research-stage compounds.
Fourth Quarter and Full Year 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $373.6 million as of December 31, 2020, as compared to $381.1 million as of December 31, 2019.
Revenue: Total revenue for the fourth quarter of 2020 was $8.4 million, compared to $4.3 million for the fourth quarter of 2019. Total revenue for the full year ended December 31, 2020 was $15.8 million, comprised of $11.5 million in net sales of TAZVERIK in the U.S. and $4.3 million in collaboration revenue, of which $3.9 million relates to deferred revenue that was recognized as a result of termination of a collaboration agreement with Celgene. This is compared to total revenue of $23.8 million for the full year ended December 31, 2019, all of which was collaboration revenue.
Operating Expenses: Total GAAP operating expenses were $70.5 million for the fourth quarter of 2020 and $241.2 million for the full year ended December 31, 2020, compared to $61.8 million for the fourth quarter of 2019 and $200.9 million for the full year ended December 31, 2019. Total non-GAAP adjusted operating expenses were $62.8 million for the fourth quarter of 2020 and $209.6 million for the full year ended December 31, 2020, compared to $55.2 million for the fourth quarter of 2019 and $162.2 million for the full year ended December 31, 2019.
Cost of product revenue: GAAP cost of product revenue was $1.8 million for the fourth quarter of 2020 and $5.1 million for the full year ended December 31, 2020, which reflects the costs of TAZVERIK units sold, amortization of intangible assets and third-party royalties on net product revenue. Non-GAAP adjusted cost of product revenue was $0.8 million for the fourth quarter of 2020 and $2.1 million for the full year ended December 31, 2020.
R&D expenses: GAAP R&D expenses were $33.7 million for the fourth quarter of 2020 and $110.9 million for the full year ended December 31, 2020, compared to $38.3 million for the fourth quarter of 2019 and $132.6 million for the full year ended December 31, 2019. Non-GAAP adjusted R&D expenses were $31.5 million for the fourth quarter of 2020 and $101.3 million for the full year ended December 31, 2020, compared to $35.8 million for the fourth quarter of 2019 and $105.8 million for the full year ended December 31, 2019.
SG&A expenses: GAAP SG&A expenses were $35.0 million for the fourth quarter of 2020 and $125.2 million for the full year ended December 31, 2020, compared to $23.5 million for the fourth quarter of 2019 and $68.3 million for the full year ended December 31, 2019. Non-GAAP adjusted SG&A expenses were $30.5 million for the fourth quarter of 2020 and $106.2 million for the full year ended December 31, 2020, compared to $19.4 million for the fourth quarter of 2019 and $56.4 million for the full year ended December 31, 2019.
Net Loss (GAAP): Net loss attributable to common stockholders was $66.2 million, or $0.65 per share, for the fourth quarter of 2020 and $231.7 million, or $2.29 per share, for the full year ended December 31, 2020, compared to $56.4 million, or $0.59 per share, for the fourth quarter of 2019 and $173.2 million, or $1.93 per share, for the full year ended December 31, 2019.
2021 Financial Guidance

Based on its current operating plans, Epizyme expects its current cash runway to extend into 2023. Additionally, the Company expects its non-GAAP adjusted operating expenses for 2021 to be between $235 and $255 million.
A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.
Conference Call Information

Epizyme will host a conference call today, February 23, at 8:00 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 3719819. A webcast, as well as supplemental slides to support the webcast, will be available in the investor section of the Company’s website at www.epizyme.com, and will be archived for 60 days following the call.

About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical and projected basis, non-GAAP adjusted R&D expenses on a historical basis and non-GAAP adjusted SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure, that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense, depreciation and amortization of intangibles and milestone payments related to TAZVERIK that are payable under the company’s collaboration agreement with Eisai Pharmaceuticals. The company’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to the company’s inability to predict with reasonable certainty the amount of future stock-based compensation expense.

About TAZVERIK

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.